Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphangioleiomyomatosis | Lymphangioleiomyomatosis | ONTOLOGY_EXACT | 0.98 |
| Tuberous Sclerosis Complex | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [11C]acetate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients will undergo [11C]acetate PET/CT
- description
- Patients will undergo a single \[11c\]acetate PET scan OR Patients will undergo an \[11c\]acetate PET scan, initiate treatment with rapamycin or rapalogs and receive a second \[11c\]acetate PET scan 3 or 4 months after starting the treatment.
- interventionNames
- Drug: [11C]acetate
Primary outcomes (1)
- measure
- Quantitative Analysis of [11C]Acetate Uptake in LAM Lesions
- timeFrame
- Single assessment (day of imaging)
- description
- Standardized uptake value (SUV) will be used to quantify uptake of \[11C\]acetate in kidney angiomyolipoma
Secondary outcomes (1)
- measure
- Quantitative Analysis of [11C]Acetate Uptake in LAM Lesions Following Treatment With mTORC1 Inhibitor
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
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