Patients will undergo [11C]acetate PET/CT for Lymphangioleiomyomatosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brigham and Women's Hospital, Boston, MA
Lymphangioleiomyomatosis+3 More
[11C]acetate - Drug
Eligibility
18+
Female
What conditions do you have?
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Study 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.

Eligible Conditions

  • Lymphangioleiomyomatosis
  • Tuberous Sclerosis Complex (TSC)

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 4 months

4 months
Feasibility of [11C]acetate PET as a biomarker of mTORC1 inhibition in LAM/TSC proliferative lesions
Quantitative analysis of [11C]acetate uptake in renal angiomyolipoma and pulmonary LAM

Trial Safety

Trial Design

1 Treatment Group

Patients will undergo [11C]acetate PET/CT
1 of 1
Experimental Treatment

16 Total Participants · 1 Treatment Group

Primary Treatment: Patients will undergo [11C]acetate PET/CT · No Placebo Group · Phase 1 & 2

Patients will undergo [11C]acetate PET/CT
Drug
Experimental Group · 1 Intervention: [11C]acetate · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months

Trial Background

Prof. Carmen Priolo M.D., Ph.D., Assistant Professor of Medicine
Principal Investigator
Brigham and Women's Hospital
Closest Location: Brigham and Women's Hospital · Boston, MA
Photo of Boston  1Photo of Boston  2Photo of Boston  3
2008First Recorded Clinical Trial
4 TrialsResearching Lymphangioleiomyomatosis
1041 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
At least one renal angiomyolipoma (at least 1 cm in each diameter) confirmed by CT or MRI.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.