Glutamine PET Imaging in LAM

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Vanderbilt University Medical Center

Status and phase

Completed
Phase 1

Conditions

Lymphangioleiomyomatosis (LAM)

Treatments

Drug: Glutamine

Study type

Interventional

Funder types

Other

Identifiers

NCT04388371
190481

Details and patient eligibility

About

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.

Full 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).

Enrollment

5 patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5 participants in 2 patient groups

Prior to subject taking sirolimus or everolimus
Experimental group
Description:
To compare images from subjects prior to use of sirolimus or everolimus to images produced after use of sirolimus or everolimus.
Treatment:
Drug: Glutamine
subjects taking sirolimus or everolimus
Experimental group
Description:
To compare images from subjects prior to use of sirolimus or everolimus to images produced after use of sirolimus or everolimus.
Treatment:
Drug: Glutamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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