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Glutamine PET Imaging in LAM

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ClinicalTrials.gov Identifier: NCT04388371
Recruitment Status : Suspended (Due to COVID 19 Pandemic)
First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Sponsor:
Collaborator:
The LAM Foundation
Information provided by (Responsible Party):
Timothy Blackwell, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment Phase
Lymphangioleiomyomatosis (LAM) Drug: Glutamine Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Glutamine PET Imaging in LAM
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine

Arm Intervention/treatment
Experimental: Prior to subject taking sirolimus or everolimus
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.

Experimental: subjects taking sirolimus or everolimus
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.




Primary Outcome Measures :
  1. Evaluate the uptake of the PET tracer throughout the entire lung and any associated neoplasms (AML, Lymphangiomas) in patients with LAM [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Because LAM is a disease that occurs essentially only in females, the study population will consist of only females.
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388371


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
The LAM Foundation
Investigators
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Principal Investigator: Timothy S Blackwell, MD Vanderbilt University Medical Center
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Responsible Party: Timothy Blackwell, Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04388371    
Other Study ID Numbers: 190481
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Lymphangioleiomyomatosis
Lymphangiomyoma
Lymphatic Vessel Tumors
Neoplasms by Histologic Type
Neoplasms
Perivascular Epithelioid Cell Neoplasms
Neoplasms, Connective and Soft Tissue
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases