RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-08-30
Study Completion:2023-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05467397

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * diagnosis of LAM (or TSC-LAM)
  2. * age 18 or over
  3. * at least one renal angiomyolipoma (at least 1 cm in each diameter) confirmed by CT or MRI
  4. * 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
  1. * under treatment with rapamycin or rapalogs for \< 3 months or \> 1 year
  2. * participated in research studies involving radiation exposure (\> 50 mSv/year) in the past 12 months

Contacts and Locations

Study Contact

Carmen Priolo
CONTACT
8573070783
cpriolo@partners.org

Principal Investigator

Carmen P Priolo, MD PhD
PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

  • Carmen P Priolo, MD PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-30
Study Completion Date2023-12-31

Study Record Updates

Study Start Date2021-08-30
Study Completion Date2023-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Lymphangioleiomyomatosis
  • Tuberous Sclerosis Complex