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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: Completed Phase 1 study of Lymphangioleiomyomatosis (LAM), sponsored by Vanderbilt University Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
While these imaging techniques have not been used in normal populations, the pulmonary uptake of patients with known intraabdominal malignancy will serve as control for evaluation of any potential uptake. When comparing treatment effects, each patient can serve as their own control as they will have already had imaging completed prior to the initiation of therapy. VEGF-D levels will be collected from clinical laboratory assessment or will be collected at time of enrollment, and relative elevatio
Conditions Studied
Interventions
- DRUG Glutamine
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-10-18 |
| Est. Completion | 2021-08-10 |
| Phase | Phase 1 |
What the finished NCT04388371 record still lists
NCT04388371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 50-participant average among 3 other Lymphangioleiomyomatosis (LAM) trials with a reported enrollment target (90% lower).
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 a single indexed study location in 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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