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 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.

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Key information

Conditions

Lymphangioleiomyomatosis (LAM) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphangioleiomyomatosis Lymphangiomyoma Lymphatic Diseases Lymphoproliferative Disorders Neoplasm, Lymphatic Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Perivascular Epithelioid Cell Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

glutamine

Drug

Glutamine will be administered by IV injection prior to PET imaging.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

The LAM Foundation

Registry information

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: May 14, 2020
Registry last updated: Aug 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed