Glutamine PET Imaging in LAM

• Status: Completed
• Trial end date: 2021-08-10
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborator: The LAM Foundation

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