Ignite Creation Date:
2024-05-06 @ 2:38 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04388371
Status:
COMPLETED
Last Update Posted:
2021-08-11
First Post:
2020-05-11
Brief Title:
Glutamine PET Imaging in LAM
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Glutamine PET Imaging in LAM
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 PETCT 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 PETCT scan
Detailed Description:
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 PETCT will demonstrate uptake within the lungs andor 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 PETCT 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 PETCT 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
The objective is to test the hypothesis that 11C-Glutamine PETCT will demonstrate uptake within the lungs andor 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 PETCT 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 PETCT 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None