11C-Glutamine PET/CT for the Diagnosis of Lymphangioleiomyomatosis

This phase I trial evaluates the use of 11C-glutamine PET/CT in diagnosing patients with lymphangioleiomyomatosis. Lymphangioleiomyomatosis (LAM) is a disease that affects the lungs and is associated with tumors of the kidney called angiomyolipomas (AMLs). PET imaging is potentially more sensitive than standard imaging methods such as magnetic resonance imaging (MRI) or x-ray computed tomography (CAT/CT) scanning. Diagnostic procedures, such as 11C-glutamine PET/CT, may help find and diagnose lymphangioleiomyomatosis and help measure a patient's response to earlier treatment. The purpose of this trial is to determine how well 11C-glutamine can detect the activity of lung disease and/or the activity of any AMLs and develop better ways to diagnose and monitor disease activity in patients with LAM, including the effect of therapies on LAM patients.

Inclusion Criteria

>= 18 years of age
Diagnosis of LAM via either * Histopathologic diagnosis * Compatible CT chest and one of the following ** Tuberous sclerosis complex *** The diagnosis of tuberous sclerosis complex (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 ** Angiomyolipoma or lymphangioma ** Chylous Effusion ** Serum VEGF-D level > 800 pg/mL

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

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04388371.

PRIMARY OBJECTIVE:

I. To test the hypothesis that carbon C 11 glutamine (11C-glutamine) positron emission tomography (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.

OUTLINE:

Patients receive carbon C 11 glutamine intravenously (IV) and then undergo PET/CT over 65 minutes.

Trial PhasePhase I

Trial Typediagnostic

Lead OrganizationVanderbilt University/Ingram Cancer Center

Principal InvestigatorTimothy S. Blackwell

Primary IDVICCTHO20106
Secondary IDsNCI-2021-00337, 190481
ClinicalTrials.gov IDNCT04388371

11C-Glutamine PET/CT for the Diagnosis of Lymphangioleiomyomatosis

Inclusion Criteria

Exclusion Criteria

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11C-Glutamine PET/CT for the Diagnosis of Lymphangioleiomyomatosis

Description

Eligibility Criteria

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Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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