Trial Outcomes & Findings for Novel PET Radioligand as an Inflammatory Biomarker in Musculoskeletal Conditions (NCT NCT03912428)
NCT ID: NCT03912428
Last Updated: 2025-09-16
Results Overview
The uptake of \[11C\]MC1 before (baseline) and after blockade by single dose of celecoxib 400mg orally in inflamed regions of the body in patients. The radioligand uptake of \[11C\]MC1 during whole body PET/CT scans in selected regions of interest was quantified as a Standardized Uptake Value (SUV), which normalizes for injected activity and body weight, using Bruker's PMOD quantification software.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
31 participants
Primary outcome timeframe
Up to 120 minutes during each scan
Results posted on
2025-09-16
Participant Flow
31 participants signed consent \- One subject withdrew after signing consent and prior to start of study interventions
Participant milestones
| Measure |
Phase 1: Pilot - Whole Body PET/CT Scan in Health Participants
Healthy participants receive about 10 mCi of \[11C\]MC1 intravenously followed by a whole body PET/CT scan. If radiation dose to selected body organs is within safety limit, Phase 2 of study was initiated
|
Phase 2: Whole Body PET/CT Scans in Patients
Participants with rheumatoid arthritis (RA), idiopathic inflammatory myopathies (IIM), or axial spondyloarthritis (AXSPA), had a baseline whole body PET/CT scan after about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
Phase 2: Whole Body PET/CT Scans in Healthy Participants
Healthy participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day. In a second visit, participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]ER176 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]ER176 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
Phase 3: Brain PET/CT Scans in Healthy Participants
Healthy participants had a baseline brain PET/CT scan after receiving about 20 mCi \[11C\]MC1 followed by a second brain PET/CT scan with 20 mCi \[11C\]MC1 intravenously after blockade with single dose of celecoxib 600 mg orally on same day. Participants had arterial blood sampling with each brain scan.
|
|---|---|---|---|---|
|
Phase 1: Pilot, Dosimetry
STARTED
|
2
|
0
|
0
|
0
|
|
Phase 1: Pilot, Dosimetry
COMPLETED
|
2
|
0
|
0
|
0
|
|
Phase 1: Pilot, Dosimetry
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Phase 2: Whole Body PET/CT Scans
STARTED
|
0
|
14
|
2
|
0
|
|
Phase 2: Whole Body PET/CT Scans
COMPLETED
|
0
|
9
|
1
|
0
|
|
Phase 2: Whole Body PET/CT Scans
NOT COMPLETED
|
0
|
5
|
1
|
0
|
|
Phase 3: Brain PET/CT Scans
STARTED
|
0
|
0
|
0
|
12
|
|
Phase 3: Brain PET/CT Scans
COMPLETED
|
0
|
0
|
0
|
10
|
|
Phase 3: Brain PET/CT Scans
NOT COMPLETED
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Phase 1: Pilot - Whole Body PET/CT Scan in Health Participants
Healthy participants receive about 10 mCi of \[11C\]MC1 intravenously followed by a whole body PET/CT scan. If radiation dose to selected body organs is within safety limit, Phase 2 of study was initiated
|
Phase 2: Whole Body PET/CT Scans in Patients
Participants with rheumatoid arthritis (RA), idiopathic inflammatory myopathies (IIM), or axial spondyloarthritis (AXSPA), had a baseline whole body PET/CT scan after about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
Phase 2: Whole Body PET/CT Scans in Healthy Participants
Healthy participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day. In a second visit, participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]ER176 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]ER176 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
Phase 3: Brain PET/CT Scans in Healthy Participants
Healthy participants had a baseline brain PET/CT scan after receiving about 20 mCi \[11C\]MC1 followed by a second brain PET/CT scan with 20 mCi \[11C\]MC1 intravenously after blockade with single dose of celecoxib 600 mg orally on same day. Participants had arterial blood sampling with each brain scan.
|
|---|---|---|---|---|
|
Phase 2: Whole Body PET/CT Scans
Physician Decision
|
0
|
2
|
0
|
0
|
|
Phase 2: Whole Body PET/CT Scans
Withdrawal by Subject
|
0
|
3
|
1
|
0
|
|
Phase 3: Brain PET/CT Scans
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Novel PET Radioligand as an Inflammatory Biomarker in Musculoskeletal Conditions
Baseline characteristics by cohort
| Measure |
Phase 1: Pilot - Whole Body PET/CT Scan in Health Participants
n=2 Participants
Healthy participants receive about 10 mCi of \[11C\]MC1 intravenously followed by a whole body PET/CT scan. If radiation dose to selected body organs is within safety limit, Phase 2 of study was initiated
|
Phase 2: Whole Body PET/CT Scans in Patients
n=14 Participants
Participants with rheumatoid arthritis (RA), idiopathic inflammatory myopathies (IIM), or axial spondyloarthritis (AXSPA), had a baseline whole body PET/CT scan after about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
Phase 2: Whole Body PET/CT Scans in Healthy Participants
n=2 Participants
Healthy participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day. In a second visit, participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]ER176 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]ER176 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
Phase 3: Brain PET/CT Scans in Healthy Participants
n=12 Participants
Healthy participants had a baseline brain PET/CT scan after receiving about 20 mCi \[11C\]MC1 followed by a second brain PET/CT scan with 20 mCi \[11C\]MC1 intravenously after blockade with single dose of celecoxib 600 mg orally on same day. Participants had arterial blood sampling with each brain scan.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 120 minutes during each scanPopulation: Participants who completed phase 1 of the study.
Participant received whole body PET/CT scan and radioligand uptake of \[11C\]MC1 in selected body regions of interest was quantified as a Standardized Uptake Value (SUV) using the Siemens Biograph Micro-Computed Tomography (mCT) with an injected dose of 9 mCi. Organ dosimetry was measured as dose per organ in Roentgen Equivalent Man (rem), which is absorbed dose times an organ-specific quality factor.
Outcome measures
| Measure |
Phase 2: Whole Body PET/CT Scans in Healthy Participants
n=2 Participants
Healthy participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day. In a second visit, participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]ER176 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]ER176 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
|---|---|
|
Uptake of [11C]MC1 by Organs
Adrenals
|
0.11057425 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00536093
|
|
Uptake of [11C]MC1 by Organs
Brain
|
0.15445975 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00748861
|
|
Uptake of [11C]MC1 by Organs
Esophagus
|
0.06978655 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00338344
|
|
Uptake of [11C]MC1 by Organs
Extrathoracic Tissue
|
0.00000000 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00000000
|
|
Uptake of [11C]MC1 by Organs
Gallbladder Wall
|
0.54211500 (Roentgen Equivalent Man (rem)
Standard Deviation 0.02628316
|
|
Uptake of [11C]MC1 by Organs
GI-tract: Lower Large Intestine
|
0.07955323 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00385695
|
|
Uptake of [11C]MC1 by Organs
Small Intestine
|
0.17037900 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00826042
|
|
Uptake of [11C]MC1 by Organs
Stomach
|
0.11414533 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00553407
|
|
Uptake of [11C]MC1 by Organs
GI-tract: Upper Large Intestine
|
0.17511175 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00848988
|
|
Uptake of [11C]MC1 by Organs
Colon
|
0.13402158 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00649772
|
|
Uptake of [11C]MC1 by Organs
Heart Wall
|
0.14198250 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00688368
|
|
Uptake of [11C]MC1 by Organs
Kidneys
|
0.21555525 (Roentgen Equivalent Man (rem)
Standard Deviation 0.01045068
|
|
Uptake of [11C]MC1 by Organs
Liver
|
0.57352325 (Roentgen Equivalent Man (rem)
Standard Deviation 0.02780591
|
|
Uptake of [11C]MC1 by Organs
Lungs
|
0.11444650 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00554867
|
|
Uptake of [11C]MC1 by Organs
Lymph Nodes
|
0.00000000 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00000000
|
|
Uptake of [11C]MC1 by Organs
Muscle
|
0.06802253 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00329791
|
|
Uptake of [11C]MC1 by Organs
Oral Mucosa
|
0.00000000 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00000000
|
|
Uptake of [11C]MC1 by Organs
Pancreas
|
0.10799275 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00523577
|
|
Uptake of [11C]MC1 by Organs
Red Marrow
|
0.19146125 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00928254
|
|
Uptake of [11C]MC1 by Organs
Salivary Glands
|
0.00000000 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00000000
|
|
Uptake of [11C]MC1 by Organs
Bone Surfaces
|
0.16822775 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00815612
|
|
Uptake of [11C]MC1 by Organs
Skin
|
0.05287773 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00256365
|
|
Uptake of [11C]MC1 by Organs
Spleen
|
0.08863150 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00429709
|
|
Uptake of [11C]MC1 by Organs
Thymus
|
0.06978655 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00338344
|
|
Uptake of [11C]MC1 by Organs
Thyroid
|
0.06346188 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00307680
|
|
Uptake of [11C]MC1 by Organs
Urinary Bladder Wall 3
|
0.20565950 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00997091
|
|
Uptake of [11C]MC1 by Organs
Lens
|
0.05287773 (Roentgen Equivalent Man (rem)
Standard Deviation 0.00256365
|
|
Uptake of [11C]MC1 by Organs
Effective Dose
|
0.14000000 (Roentgen Equivalent Man (rem)
Standard Deviation 0.01000000
|
PRIMARY outcome
Timeframe: Up to 120 minutes during each scanPopulation: Participants who completed phase 1 of the study.
Participant received whole body PET/CT scan and radioligand uptake of \[11C\]MC1 in selected body regions of interest was quantified as a Standardized Uptake Value (SUV) using the Siemens Biograph Micro-Computed Tomography (mCT) with an injected dose of 9 mCi. Organ dosimetry was measured as dose per organ in Roentgen Equivalent Man (rem), which is absorbed dose times an organ-specific quality factor.
Outcome measures
| Measure |
Phase 2: Whole Body PET/CT Scans in Healthy Participants
n=2 Participants
Healthy participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day. In a second visit, participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]ER176 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]ER176 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
|---|---|
|
Uptake of [11C]MC1 by Organs - Gender Specific Organs
Breasts - Female only
|
0.05700660 Roentgen Equivalent Man (rem)
|
|
Uptake of [11C]MC1 by Organs - Gender Specific Organs
Ovaries - Female only
|
0.08372325 Roentgen Equivalent Man (rem)
|
|
Uptake of [11C]MC1 by Organs - Gender Specific Organs
Testes - Male only
|
0.15045450 Roentgen Equivalent Man (rem)
|
|
Uptake of [11C]MC1 by Organs - Gender Specific Organs
Uterus - Female only
|
0.08310000 Roentgen Equivalent Man (rem)
|
PRIMARY outcome
Timeframe: Up to 120 minutes during each scanPopulation: Per protocol document, analysis only applies to patients. Data analysis was done on participants who had usable data.
The uptake of \[11C\]MC1 before (baseline) and after blockade by single dose of celecoxib 400mg orally in inflamed regions of the body in patients. The radioligand uptake of \[11C\]MC1 during whole body PET/CT scans in selected regions of interest was quantified as a Standardized Uptake Value (SUV), which normalizes for injected activity and body weight, using Bruker's PMOD quantification software.
Outcome measures
| Measure |
Phase 2: Whole Body PET/CT Scans in Healthy Participants
n=2 Participants
Healthy participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day. In a second visit, participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]ER176 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]ER176 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
|---|---|
|
Phase 2: [11C]MC1 Binding in Inflamed Body Parts - HANDS
Baseline
|
1.1920415496 Standard Uptake Value (SUV)
Standard Deviation 0.29838844946
|
|
Phase 2: [11C]MC1 Binding in Inflamed Body Parts - HANDS
Blocked
|
1.190292618 Standard Uptake Value (SUV)
Standard Deviation 0.027520757
|
PRIMARY outcome
Timeframe: Up to 120 minutes during each scanPopulation: Per protocol document, analysis only applies to healthy participants. Data analysis was done on participants who had usable data.
The uptake of \[11C\]MC1 before (baseline) and after blockade by a single dose of celecoxib 400mg orally in non-inflamed regions of the body in healthy participants. The radioligand uptake of \[11C\]MC1 during whole body PET/CT scans in selected regions of interest was quantified as a Standardized Uptake Value (SUV), which normalizes for injected activity and body weight, using Bruker's PMOD quantification software.
Outcome measures
| Measure |
Phase 2: Whole Body PET/CT Scans in Healthy Participants
n=2 Participants
Healthy participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day. In a second visit, participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]ER176 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]ER176 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
|---|---|
|
Phase 2: [11C]MC1 Binding in Non-inflamed Body Parts - HANDS
Baseline
|
0.07 Standard Uptake Value (SUV)
Standard Deviation 0.000509
|
|
Phase 2: [11C]MC1 Binding in Non-inflamed Body Parts - HANDS
Blocked
|
0.13 Standard Uptake Value (SUV)
Standard Deviation 0.074459
|
PRIMARY outcome
Timeframe: Up to 120 minutes during each scanPopulation: Per protocol document, analysis only applies to patients. Data analysis was done on participants who had usable data.
The uptake of \[11C\]MC1 before (baseline) and after blockade by a single dose of celecoxib 400mg orally in inflamed regions of the body in patients. The radioligand uptake of \[11C\]MC1 during whole body PET/CT scans in selected regions of interest was quantified as a Standardized Uptake Value (SUV), which normalizes for injected activity and body weight, using Bruker's PMOD quantification software.
Outcome measures
| Measure |
Phase 2: Whole Body PET/CT Scans in Healthy Participants
n=4 Participants
Healthy participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day. In a second visit, participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]ER176 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]ER176 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
|---|---|
|
Phase 2: [11C]MC1 Binding in Inflamed Body Parts - KNEES
Baseline
|
0.51298372752 Standard Uptake Value (SUV)
Standard Deviation 0.071065370092
|
|
Phase 2: [11C]MC1 Binding in Inflamed Body Parts - KNEES
Blocked
|
0.565377936 Standard Uptake Value (SUV)
Standard Deviation 0.218519988
|
PRIMARY outcome
Timeframe: Up to 120 minutes during each scanPopulation: Per protocol document, analysis only applies to healthy participants. There was no usable data for analysis as the signal was not detected within the imaging window.
The uptake of \[11C\]MC1 before (baseline) and after blockade by a single dose of celecoxib 400mg orally in non-inflamed regions of the body in healthy participants. The radioligand uptake of \[11C\]MC1 during whole body PET/CT scans in selected regions of interest was quantified as a Standardized Uptake Value (SUV), which normalizes for injected activity and body weight, using Bruker's PMOD quantification software.
Outcome measures
| Measure |
Phase 2: Whole Body PET/CT Scans in Healthy Participants
n=2 Participants
Healthy participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day. In a second visit, participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]ER176 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]ER176 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
|---|---|
|
Phase 2: [11C]MC1 Binding Between Non-inflamed Body - KNEES
Baseline
|
NA Standard Uptake Value (SUV)
Standard Deviation NA
There was no usable data for analysis as the signal was not detected within the imaging window.
|
|
Phase 2: [11C]MC1 Binding Between Non-inflamed Body - KNEES
Blocked
|
NA Standard Uptake Value (SUV)
Standard Deviation NA
There was no usable data for analysis as the signal was not detected within the imaging window.
|
PRIMARY outcome
Timeframe: Up to 120 minutes during each scanPopulation: Participants who completed the PET/CT brain scans in Phase 3 of the study
The volume of distribution (VT) of \[11C\]MC1 measured as the brain-to-plasma ratio using the 2-tissue compartmental modeling divided by free-fraction in the plasma of parent radioligand (fP) at baseline and two hours after blockade with single dose of 600 mg celecoxib orally.
Outcome measures
| Measure |
Phase 2: Whole Body PET/CT Scans in Healthy Participants
n=10 Participants
Healthy participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day. In a second visit, participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]ER176 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]ER176 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
|---|---|
|
Whole Brain Volume of Distribution (VT)/ Free-fraction (fP) of [11C]MC1
Blocked
|
81 mL/cm^3
Standard Deviation 12
|
|
Whole Brain Volume of Distribution (VT)/ Free-fraction (fP) of [11C]MC1
Baseline
|
109 mL/cm^3
Standard Deviation 16
|
Adverse Events
Phase 1: Pilot - Whole Body PET/CT Scan in Health Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phase 2: Whole Body PET/CT Scans in Patients
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2: Whole Body PET/CT Scans in Healthy Participants
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 3: Brain PET/CT Scans in Healthy Participants
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1: Pilot - Whole Body PET/CT Scan in Health Participants
n=2 participants at risk
Healthy participants receive about 10 mCi of \[11C\]MC1 intravenously followed by a whole body PET/CT scan. If radiation dose to selected body organs is within safety limit, Phase 2 of study was initiated
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Phase 2: Whole Body PET/CT Scans in Patients
n=14 participants at risk
Participants with rheumatoid arthritis (RA), idiopathic inflammatory myopathies (IIM), or axial spondyloarthritis (AXSPA), had a baseline whole body PET/CT scan after about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
Phase 2: Whole Body PET/CT Scans in Healthy Participants
n=2 participants at risk
Healthy participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]MC1 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]MC1 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day. In a second visit, participants had a baseline whole body PET/CT scan after receiving about 15 mCi of \[11C\]ER176 followed by a second whole body PET/CT scan with about 15 mCi of \[11C\]ER176 intravenously after blockade with single dose of celecoxib 200-400 mg orally on same day.
|
Phase 3: Brain PET/CT Scans in Healthy Participants
n=12 participants at risk
Healthy participants had a baseline brain PET/CT scan after receiving about 20 mCi \[11C\]MC1 followed by a second brain PET/CT scan with 20 mCi \[11C\]MC1 intravenously after blockade with single dose of celecoxib 600 mg orally on same day. Participants had arterial blood sampling with each brain scan.
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|---|---|---|---|---|
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General disorders
Burning sensation
|
0.00%
0/2 • Up to two days after each PET/CT scan visit
|
7.1%
1/14 • Up to two days after each PET/CT scan visit
|
0.00%
0/2 • Up to two days after each PET/CT scan visit
|
8.3%
1/12 • Up to two days after each PET/CT scan visit
|
|
General disorders
Injection site haematoma
|
0.00%
0/2 • Up to two days after each PET/CT scan visit
|
0.00%
0/14 • Up to two days after each PET/CT scan visit
|
0.00%
0/2 • Up to two days after each PET/CT scan visit
|
8.3%
1/12 • Up to two days after each PET/CT scan visit
|
|
General disorders
Injection site paraesthesia
|
0.00%
0/2 • Up to two days after each PET/CT scan visit
|
0.00%
0/14 • Up to two days after each PET/CT scan visit
|
0.00%
0/2 • Up to two days after each PET/CT scan visit
|
8.3%
1/12 • Up to two days after each PET/CT scan visit
|
|
General disorders
Medical device site pain
|
0.00%
0/2 • Up to two days after each PET/CT scan visit
|
0.00%
0/14 • Up to two days after each PET/CT scan visit
|
0.00%
0/2 • Up to two days after each PET/CT scan visit
|
8.3%
1/12 • Up to two days after each PET/CT scan visit
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • Up to two days after each PET/CT scan visit
|
0.00%
0/14 • Up to two days after each PET/CT scan visit
|
0.00%
0/2 • Up to two days after each PET/CT scan visit
|
8.3%
1/12 • Up to two days after each PET/CT scan visit
|
|
Skin and subcutaneous tissue disorders
Medical device site rash
|
0.00%
0/2 • Up to two days after each PET/CT scan visit
|
0.00%
0/14 • Up to two days after each PET/CT scan visit
|
50.0%
1/2 • Up to two days after each PET/CT scan visit
|
0.00%
0/12 • Up to two days after each PET/CT scan visit
|
Additional Information
Dr. Robert Innis
National Institute of Mental Health
Phone: +1 301 594 1368
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place