NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Feasibility of [11C]Acetate-PET in LAM and TSC

Active Not RecruitingPhase 1, Phase 2

Sponsor: Brigham and Women's Hospital

Conditions: Lymphangioleiomyomatosis, Tuberous Sclerosis Complex

Interventions: [11C]acetate

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Boston, Massachusetts, United States