Trial Outcomes & Findings for Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma (NCT NCT03262389)
NCT ID: NCT03262389
Last Updated: 2021-03-16
Results Overview
The number of lesions detected in the scans will be averaged for each technique. Two techniques (scans) will be tested on Day 1 and two techniques (scans) will be tested on Day 2.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Day 1, Day 2
Results posted on
2021-03-16
Participant Flow
Participant milestones
| Measure |
Multiple Myeloma (MM) Patients
New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.
Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).
Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).
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|---|---|
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Overall Study
STARTED
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10
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|
Overall Study
COMPLETED
|
7
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|
Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Multiple Myeloma (MM) Patients
New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.
Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).
Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).
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|---|---|
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Overall Study
Machine malfunction Day 1, no return Day 2
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1
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Overall Study
opted out of the study once his clinical FDG PET CT was done.
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1
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Overall Study
opted out of PET/MR
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1
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Baseline Characteristics
Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Multiple Myeloma (MM) Patients
n=10 Participants
New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.
Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).
Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).
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|---|---|
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Age, Continuous
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64.4 years
STANDARD_DEVIATION 11.2 • n=99 Participants
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|
Sex: Female, Male
Female
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3 Participants
n=99 Participants
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Sex: Female, Male
Male
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7 Participants
n=99 Participants
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Race/Ethnicity, Customized
White
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7 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
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1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
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2 Participants
n=99 Participants
|
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Region of Enrollment
United States
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10 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Day 1, Day 2Population: Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups.
The number of lesions detected in the scans will be averaged for each technique. Two techniques (scans) will be tested on Day 1 and two techniques (scans) will be tested on Day 2.
Outcome measures
| Measure |
Multiple Myeloma (MM) Patients
n=7 Participants
New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.
Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).
Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).
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|---|---|
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Mean Multiple Myeloma Lesions Detected
C-11 acetate PET CT
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4.6 number of lesions
Standard Deviation 5.1
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Mean Multiple Myeloma Lesions Detected
C-11 acetate PET MRI
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4.4 number of lesions
Standard Deviation 5.2
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Mean Multiple Myeloma Lesions Detected
18 FDG PET CT
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1.1 number of lesions
Standard Deviation 1.7
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Mean Multiple Myeloma Lesions Detected
18 FDG PET MRI
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1.0 number of lesions
Standard Deviation 1.8
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SECONDARY outcome
Timeframe: Approximately one month after Day 2Population: Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups.
The visual image analysis scale has a range of 0-4: (0 no uptake; 1 benign, 2 probably benign, 3 probably malignant, 4 malignant).
Outcome measures
| Measure |
Multiple Myeloma (MM) Patients
n=7 Participants
New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.
Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).
Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).
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|---|---|
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Visual Image Analysis of Detected Multiple Myeloma Lesions
C-11 acetate PET CT
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3.1 score on a scale
Standard Deviation 1.9
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Visual Image Analysis of Detected Multiple Myeloma Lesions
C-11 acetate PET MRI
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3.3 score on a scale
Standard Deviation 1.8
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Visual Image Analysis of Detected Multiple Myeloma Lesions
18 FDG PET CT
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1.9 score on a scale
Standard Deviation 2.0
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Visual Image Analysis of Detected Multiple Myeloma Lesions
18 FDG PET MRI
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2.0 score on a scale
Standard Deviation 1.9
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Adverse Events
Multiple Myeloma (MM) Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place