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

NCT05467397 | Active Not Recruiting Phase 1 Results FDA Drug

• 1 other identifier: 2019p003557
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphangioleiomyomatosis; Tuberous Sclerosis Complex

Outcome Measures

Primary Outcomes (1)

• Quantitative Analysis of [11C]Acetate Uptake in LAM Lesions

  Standardized uptake value (SUV) will be used to quantify uptake of \[11C\]acetate in kidney angiomyolipoma

  Single assessment (day of imaging)

Secondary Outcomes (1)

• Quantitative Analysis of [11C]Acetate Uptake in LAM Lesions Following Treatment With mTORC1 Inhibitor

  Single assessment conducted while participants were on treatment with mTORC1 inhibitor (day of imaging)

Study Arms (1)

Patients will undergo [11C]acetate PET/CT

EXPERIMENTAL

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.

Drug: [11C]acetate

Interventions

[11C]acetate DRUG

Positron Emission Tomography (PET)

Also known as: diagnostic test

Patients will undergo [11C]acetate PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Lymphangioleiomyomatosis; Tuberous Sclerosis

Interventions

carbon-11 acetate

Condition Hierarchy (Ancestors)

Lymphangiomyoma; Neoplasm, Lymphatic Tissue; Neoplasms by Histologic Type; Neoplasms; Perivascular Epithelioid Cell Neoplasms; Neoplasms, Connective and Soft Tissue; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hamartoma; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Results Point of Contact

• Title: Carmen Priolo, MD PhD
• Organization: Brigham and Women's Hospital, Boston, MA

cpriolo@bwh.harvard.edu

857-307-0783

Study Officials

• Carmen P Priolo, MD PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 20, 2022
• Study Start: August 30, 2021
• Primary Completion: June 4, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2026-01

Locations

US (1)