A Phase 1 interventional study of Glutamine in Lymphangioleiomyomatosis (LAM), sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-11.
Sponsored by Vanderbilt University Medical Center · Phase 1, Interventional, and Diagnostic
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.
Objectives This is a hypothesis-driven prospective pilot study of the targeted PET reagent 11C-Glutamine in LAM.
The objective is to test the hypothesis that 11C-Glutamine PET/CT will demonstrate uptake within the lungs and/or associated neoplasm of patients with LAM and that this effect will be modified by treatment with mTOR inhibitors.
Rationale Our rationale is that 11C-Glutamine PET/CT may provide an improved ability to diagnose LAM, as well as predict and monitor treatment response to mTOR inhibitors.
Aims Test the hypothesis that 11C-Gln PET imaging of the lungs in humans will reflect the known "glutamine addiction" seen in mechanistic preclinical studies of LAM. As a result, PET imaging will show increased tracer uptake in affected areas of diseased lungs and will show reduced uptake after initiating treatment with mTOR inhibitors.
Approach: We will evaluate 11C-Glutamine PET/CT uptake in patients with known LAM, and if possible, we will test subjects again after 8 weeks of mTOR inhibitor therapy (either sirolimus or everolimus).
46 studies on the registry are indexed under Lymphangioleiomyomatosis; 11 are open to participants now.
This study's enrollment of 5 is below the median of 24 across 29 interventional studies indexed under Lymphangioleiomyomatosis.
Browse Lymphangioleiomyomatosis studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Diagnosis of LAM via either a. Histopathologic diagnosis b. Compatible CT chest and one of the following i. Tuberous Sclerosis Complex* ii. Angiomyolipoma or lymphangioma iii. Chylous Effusion iv. Serum VEGF-D level >800 pg/mL
Exclusion Criteria:
To compare images from subjects prior to use of sirolimus or everolimus to images produced after use of sirolimus or everolimus.
Drug: Glutamine
To compare images from subjects prior to use of sirolimus or everolimus to images produced after use of sirolimus or everolimus.
Drug: Glutamine
Glutamine will be administered by IV injection prior to PET imaging.
Evaluate the uptake of the PET tracer throughout the entire lung and any associated neoplasms (AML, Lymphangiomas) in patients with LAM
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 elevation of VEGF-D will be compared to the relative uptake of tracer within the pulmonary parenchyma of each individual patient.
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University Medical Center