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Search / Trial NCT05467397

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

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Jul 18, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring a new imaging technique called \[11C\]acetate PET/CT to better understand two conditions: lymphangioleiomyomatosis (LAM) and tuberous sclerosis complex (TSC). The goal is to see if this imaging can be used as a marker to identify kidney tumors known as angiomyolipomas and to evaluate how well patients with LAM respond to treatment with a drug called rapamycin. Researchers believe that tumors related to TSC might process certain nutrients differently than normal tissues, which could help doctors assess the disease more effectively.

To participate in this study, women aged 18 and older with a diagnosis of LAM or TSC-LAM and at least one confirmed kidney tumor are eligible. Participants will undergo one or two PET/CT scans over a period of 3 to 6 months at Massachusetts General Hospital in Boston. An intravenous line will be used to administer a small amount of \[11C\]acetate, which is a radioactive substance that quickly leaves the body after the scan. It’s important to note that those currently receiving rapamycin for less than three months or more than a year are not eligible, as well as anyone who has recently participated in other studies involving significant radiation exposure. This study is currently recruiting participants, and your involvement could help advance understanding and treatment of these conditions.

Gender

FEMALE

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

About Brigham And Women's Hospital

Brigham and Women's Hospital (BWH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As an integral part of the Partners HealthCare system, BWH combines cutting-edge medical education with a focus on patient-centered care, fostering an environment that promotes groundbreaking clinical trials across various specialties. The hospital is dedicated to translating scientific discoveries into effective treatments, making significant contributions to the fields of cardiovascular medicine, oncology, and women's health, among others. With a robust infrastructure for research and a collaborative approach, BWH aims to improve patient outcomes and enhance the overall quality of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Carmen P Priolo, MD PhD

Principal Investigator

Brigham and Women's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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