Feasibility of [11C]Acetate-Positron Emission Tomography (PET) in Lymphangioleiomyomatosis and Tuberous Sclerosis Complex

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Massachusetts General Hospital

Criteria

Inclusion Criteria:

• LAM (or TSC-LAM) patients, aged 18 yrs and over, who have at least one renal angiomyolipoma (at least 1 cm in each diameter) confirmed by CT or MRI AND have not received any prior treatment with rapamycin/rapalogs OR are candidates for initiating treatment with rapamycin/rapalogs OR have been on rapamycin/rapalogs for a minimum of 3 months and maximum of 1 year will be eligible for the study.

Exclusion Criteria:

• Patients with LAM and renal angiomyolipomas who are currently on rapalogs for < 3months and > 1 year OR have participated in other research studies in the past 12 months that have involved radiation exposure, which is more than 50 mSv/year, would not be eligible for this study.