Trial Outcomes & Findings for Feasibility of [11C]Acetate-PET in LAM and TSC (NCT NCT05467397)
NCT ID: NCT05467397
Last Updated: 2026-01-21
Results Overview
Standardized uptake value (SUV) will be used to quantify uptake of \[11C\]acetate in kidney angiomyolipoma
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
7 participants
Single assessment (day of imaging)
2026-01-21
Participant Flow
Seven women with Lymphangioleiomyomatosis (LAM) and at least one renal angiomyolipoma greater than 1 cm diameter were recruited to participate in the imaging study. Patients were recruited between August 2021 and May 2024 and signed a consent form either in person or electronically.
One patient became ineligible after undergoing a renal procedure.
Participant milestones
| Measure |
Undergoing [11C]Acetate PET/CT Imaging
Patients underwent a single \[11C\]acetate positron emission tomography (PET)/computed tomography (CT) scan
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Undergoing [11C]Acetate PET/CT Imaging
Patients underwent a single \[11C\]acetate positron emission tomography (PET)/computed tomography (CT) scan
|
|---|---|
|
Overall Study
One patient became ineligible after undergoing a renal procedure.
|
1
|
Baseline Characteristics
Feasibility of [11C]Acetate-PET in LAM and TSC
Baseline characteristics by cohort
| Measure |
Undergoing [11C]Acetate PET/CT Imaging
n=7 Participants
Patients underwent a single \[11C\]acetate positron emission tomography (PET)/computed tomography (CT) scan
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=37 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=37 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=37 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=37 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: Single assessment (day of imaging)Population: These participants had not received treatment with mTORC1 inhibitors at the time of imaging
Standardized uptake value (SUV) will be used to quantify uptake of \[11C\]acetate in kidney angiomyolipoma
Outcome measures
| Measure |
Undergoing [11C]Acetate PET/CT Imaging
n=4 Participants
Patients underwent a single \[11C\]acetate positron emission tomography (PET)/computed tomography (CT) scan
|
|---|---|
|
Quantitative Analysis of [11C]Acetate Uptake in LAM Lesions
|
6.42 Standardized Uptake Value (SUV)
Standard Deviation 3.34 • Interval 1.48 to 12.29
|
SECONDARY outcome
Timeframe: Single assessment conducted while participants were on treatment with mTORC1 inhibitor (day of imaging)Population: These participants were on treatment with mTORC1 inhibitor at the time of imaging
Standardized uptake value (SUV) will be used to quantify uptake of \[11C\]acetate in kidney angiomyolipoma following treatment with mTORC1 inhibitor
Outcome measures
| Measure |
Undergoing [11C]Acetate PET/CT Imaging
n=2 Participants
Patients underwent a single \[11C\]acetate positron emission tomography (PET)/computed tomography (CT) scan
|
|---|---|
|
Quantitative Analysis of [11C]Acetate Uptake in LAM Lesions Following Treatment With mTORC1 Inhibitor
|
2.80 Standardized Uptake Value (SUV)
Standard Deviation 0.90
|
Adverse Events
Undergoing [11C]Acetate PET/CT Imaging
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carmen Priolo, MD PhD
Brigham and Women's Hospital, Boston, MA
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place