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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Carmen Priolo
cpriolo@partners.org
8573070783
Time Frame
Start Date: 2021-08-30
Estimated Completion Date: 2023-12-31
Participants
Target number of participants: 16
Treatments
Experimental: Patients will undergo [11C]acetate PET/CT
Patients will undergo a single \[11c\]acetate PET scan OR Patients will undergo an \[11c\]acetate PET scan, initiate treatment with rapamycin or rapalogs and receive a second \[11c\]acetate PET scan 3 or 4 months after starting the treatment.
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov

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