Tuberous Sclerosis Complex Clinical Trial
Official title:
Feasibility Study of [11C]Acetate Positron Emission Tomography (PET) as an Indicator of Early Response to Rapamycin in Lymphangioleiomyomatosis (LAM) Patients
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 | Recruiting |
Enrollment | 16 |
Est. completion date | December 31, 2023 |
Est. primary completion date | August 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantitative analysis of [11C]acetate uptake in renal angiomyolipoma and pulmonary LAM | Standardized uptake value (SUV) will be used to quantify uptake | 4 months | |
Secondary | Feasibility of [11C]acetate PET as a biomarker of mTORC1 inhibition in LAM/TSC proliferative lesions | Standardized uptake value (SUV) will be used to quantify uptake | 4 months |
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