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Glutamine PET Imaging in LAM

Primary Purpose

Lymphangioleiomyomatosis (LAM)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Glutamine
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphangioleiomyomatosis (LAM)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Female subjects
  2. ≥ 18 years of age

  3. 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

    • The diagnosis of TSC will be based on the presence of at least two major criteria or one major and one or more minor features per published guidelines.(30)

Exclusion Criteria:

  1. Patients with any known intrathoracic cancer (primary lung cancer or metastatic disease) or undergoing active treatment for malignancy
  2. Patients with use of investigational therapies for LAM either currently or in the prior 3 months
  3. Patients with body weight ≥400 pounds or body habitus or disability that will not permit the imaging protocol to be performed
  4. Patients known to be pregnant or breastfeeding
  5. Patients with clinically active known or suspected pulmonary infection of any type
  6. Patients known or suspected to have any inborn error of metabolism
  7. Patients with known type I diabetes mellitus
  8. Patients who cannot have a peripheral IV for any reason
  9. Patients who cannot lie flat for the duration of the PET scan
  10. Patients who are claustrophobic
  11. Patients with a prior allergy to contrast agents or to PET tracers

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Prior to subject taking sirolimus or everolimus

subjects taking sirolimus or everolimus

Arm Description

To compare images from subjects prior to use of sirolimus or everolimus to images produced after use of sirolimus or everolimus.

To compare images from subjects prior to use of sirolimus or everolimus to images produced after use of sirolimus or everolimus.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 11, 2020
Last Updated
August 10, 2021
Sponsor
Vanderbilt University Medical Center
Collaborators
The LAM Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04388371
Brief Title
Glutamine PET Imaging in LAM
Official Title
Glutamine PET Imaging in LAM
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
August 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
The LAM Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphangioleiomyomatosis (LAM)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Test 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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prior to subject taking sirolimus or everolimus
Arm Type
Experimental
Arm Description
To compare images from subjects prior to use of sirolimus or everolimus to images produced after use of sirolimus or everolimus.
Arm Title
subjects taking sirolimus or everolimus
Arm Type
Experimental
Arm Description
To compare images from subjects prior to use of sirolimus or everolimus to images produced after use of sirolimus or everolimus.
Intervention Type
Drug
Intervention Name(s)
Glutamine
Intervention Description
Glutamine will be administered by IV injection prior to PET imaging.
Primary Outcome Measure Information:
Title
Evaluate the uptake of the PET tracer throughout the entire lung and any associated neoplasms (AML, Lymphangiomas) in patients with LAM
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Because LAM is a disease that occurs essentially only in females, the study population will consist of only females.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female subjects ≥ 18 years of age 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 The diagnosis of TSC will be based on the presence of at least two major criteria or one major and one or more minor features per published guidelines.(30) Exclusion Criteria: Patients with any known intrathoracic cancer (primary lung cancer or metastatic disease) or undergoing active treatment for malignancy Patients with use of investigational therapies for LAM either currently or in the prior 3 months Patients with body weight ≥400 pounds or body habitus or disability that will not permit the imaging protocol to be performed Patients known to be pregnant or breastfeeding Patients with clinically active known or suspected pulmonary infection of any type Patients known or suspected to have any inborn error of metabolism Patients with known type I diabetes mellitus Patients who cannot have a peripheral IV for any reason Patients who cannot lie flat for the duration of the PET scan Patients who are claustrophobic Patients with a prior allergy to contrast agents or to PET tracers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy S Blackwell, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Glutamine PET Imaging in LAM

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