CompletedPhase 1

Glutamine PET Imaging in LAM

United States5 participantsStarted 2019-10-18

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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

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

What they're measuring

Evaluate the uptake of the PET tracer throughout the entire lung and any associated neoplasms (AML, Lymphangiomas) in patients with LAM

Timeframe: 8 weeks

Trial details

NCT IDNCT04388371

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06-30

View on ClinicalTrials.gov More Lymphangioleiomyomatosis (LAM) trials