Feasibility of [11C]Acetate-PET in LAM and TSC
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Lymphangioleiomyomatosis, Tuberous Sclerosis Complex
In brief
This study aims to assess \[11C\]acetate positron emission tomography (PET)/computed tomography (CT) as a biomarker for renal angiomyolipomas and pulmonary lymphangioleiomyomatosis (LAM) and an early biomarker of response to rapamycin in LAM patients. \[11C\]Acetate is a radioactive form of acetate, a nutrient commonly processed in our body's cells to generate fat and energy. Preclinical studies support the hypothesis that TSC tumors enhance lipid synthesis compared to normal tissues, suggesting that quantification of \[11C\]acetate in these tumors by PET/CT may provide a metabolic biomarker of disease. Participants in the study will undergo 1 or 2 PET/CT scans over 3 to 6 months at the Massachusetts General Hospital (Boston, MA). \[11C\]acetate is administered through an intravenous catheter. This small amount of radioactivity is short-lived and eliminated from the body within a few hours.
Key facts
- Study ID
- NCT05467397
- Run by
- Brigham and Women's Hospital
- People needed
- 7
- Starts
- 2021-08-30
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2026-01-21
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- diagnosis of LAM (or TSC-LAM)
- age 18 or over
- at least one renal angiomyolipoma (at least 1 cm in each diameter) confirmed by CT or MRI
- no prior treatment with rapamycin/rapalogs OR candidate for initiating treatment with rapamycin/rapalogs OR under treatment with rapamycin/rapalogs for minimum 3 months and maximum of 1 year
You may not qualify if…
- under treatment with rapamycin or rapalogs for < 3 months or > 1 year
- participated in research studies involving radiation exposure (> 50 mSv/year) in the past 12 months
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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