NCT05467397Active, not recruitingPhase 1/2
Feasibility of [11C]Acetate-PET in LAM and TSC
Feasibility Study of [11C]Acetate Positron Emission Tomography (PET) as an Indicator of Early Response to Rapamycin in Lymphangioleiomyomatosis (LAM) Patients
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 18 Jul 2022
- Start date
- 30 Aug 2021
- Primary completion date
- 4 Jun 2024
- Lead sponsor
- Brigham and Women's Hospital
- NCT number
- NCT05467397
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 7
- From 30 Aug 2021 to the primary completion date, 4 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.