CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 7 enrolled
Drug / intervention
[11C]acetatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05467397
NCT05467397Phase 2Active

Feasibility Study of [11C]Acetate Positron Emission Tomography (PET) as an Indicator of Early Response to Rapamycin in Lymphangioleiomyomatosis (LAM) Patients

Brigham and Women's Hospital·interventional·Posted Jul 20, 2022·Updated Jan 21, 2026

In Brief

A Phase 2 clinical trial evaluating [11C]acetate for Lymphangioleiomyomatosis and Tuberous Sclerosis Complex. Active but no longer recruiting, targeting 7 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2ActiveOverdue
20222023202420252026
First PostedJul 20, 2022
Enrollment StartAug 30, 2021
Primary CompletionJun 4, 2024
Study CompletionJun 30, 2026
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 3.9 years ago

Interventions

[11C]acetatedrug

Positron Emission Tomography (PET)