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NCT05467397 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Lymphangioleiomyomatosis and Tuberous Sclerosis Complex, sponsored by Brigham and Women's Hospital.

Active
Registry status
Phase 1
Development phase
7
Enrollment target
1
Study location

NCT05467397 is a Phase 1 study of Lymphangioleiomyomatosis and Tuberous Sclerosis Complex that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 7 participants, below the 829-participant average among 10 other Lymphangioleiomyomatosis trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05467397, a Phase 1 study of Lymphangioleiomyomatosis and Tuberous Sclerosis Complex, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
7 participants
Enrollment target
1
Study location

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.

Conditions Studied

Lymphangioleiomyomatosis Tuberous Sclerosis Complex

Interventions

  • DRUG [11C]acetate

Study Locations (1)

Massachusetts

  • Brigham and Women's Hospital - Boston

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2021-08-30
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

Brigham and Women's Hospital

937 total trials

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What the Registry Record Tells You About NCT05467397

The ClinicalTrials.gov registry entry for NCT05467397 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 829-participant average among 10 other Lymphangioleiomyomatosis trials with a reported enrollment target (99% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Lymphangioleiomyomatosis appearing as the primary indexed condition, and to 1 intervention - of which [11C]acetate is the first listed.

NCT05467397 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05467397 about?

NCT05467397 is a clinical study titled "Feasibility of [11C]Acetate-PET in LAM and TSC". 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...

What is the current status of trial NCT05467397?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2021-08-30. Estimated completion is 2026-06-30.

What conditions does trial NCT05467397 study?

This clinical trial studies the following conditions: Lymphangioleiomyomatosis, Tuberous Sclerosis Complex.

What interventions are being tested in trial NCT05467397?

The interventions under investigation include: [11C]acetate (DRUG).

Who is sponsoring clinical trial NCT05467397?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05467397 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.