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NCT04388371 · ClinicalTrials.gov registry record · Phase 1

Glutamine PET Imaging in LAM

A Phase 1 study of Lymphangioleiomyomatosis (LAM), sponsored by Vanderbilt University Medical Center.

Completed
Registry status
Phase 1
Development phase
5
Enrollment target
1
Study location

NCT04388371 is a Phase 1 study of Lymphangioleiomyomatosis (LAM) that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 5 participants, below the 50-participant average among 3 other Lymphangioleiomyomatosis (LAM) trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04388371, a Phase 1 study of Lymphangioleiomyomatosis (LAM), has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
Phase 1
Development phase
5 participants
Enrollment target
1
Study location

Study Summary

In this study, subjects with spontaneous or tuberous sclerosis complex associated lymphangioleiomyomatosis (LAM) who have not been started on therapy with mTOR inhibitors such as sirolimus or everolimus to undergo a PET/CT scan using an novel PET tracer that may better evaluate disease activity in LAM subjects both before and after the initiation of mTOR inhibitor therapy will be enrolled. The procedure for each scan will be similar, involving one administration of the novel tracer C11-glutamine followed by a whole body PET/CT scan.

Interventions

  • DRUG Glutamine

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2019-10-18
Est. Completion 2021-08-10
Phase Phase 1

What the Registry Record Tells You About NCT04388371

The ClinicalTrials.gov registry entry for NCT04388371 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 50-participant average among 3 other Lymphangioleiomyomatosis (LAM) trials with a reported enrollment target (90% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lymphangioleiomyomatosis (LAM) appearing as the primary indexed condition, and to 1 intervention - of which Glutamine is the first listed.

NCT04388371 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT04388371 about?

NCT04388371 is a clinical study titled "Glutamine PET Imaging in LAM". In this study, subjects with spontaneous or tuberous sclerosis complex associated lymphangioleiomyomatosis (LAM) who have not been started on therapy with mTOR inhibitors such as sirolimus or everolimus to undergo a PET/CT scan using an novel PET tracer that may better evaluate disease activity in L...

What is the current status of trial NCT04388371?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2019-10-18. Estimated completion is 2021-08-10.

What conditions does trial NCT04388371 study?

This clinical trial studies the following conditions: Lymphangioleiomyomatosis (LAM).

What interventions are being tested in trial NCT04388371?

The interventions under investigation include: Glutamine (DRUG).

Who is sponsoring clinical trial NCT04388371?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04388371 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.