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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: Active Phase 1 study of Lymphangioleiomyomatosis and Tuberous Sclerosis Complex, sponsored by Brigham and Women's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Standardized uptake value (SUV) will be used to quantify uptake of \[11C\]acetate in kidney angiomyolipoma
Conditions Studied
Interventions
- DRUG [11C]acetate
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What the registry record for NCT05467397 still lists
NCT05467397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 829-participant average among 10 other Lymphangioleiomyomatosis trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05467397's enrollment target sits among peer trials
7 11th of 10 the lowest of 10 other Lymphangioleiomyomatosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphangioleiomyomatosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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