Status:
COMPLETED
Glutamine PET Imaging in LAM
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
The LAM Foundation
Conditions:
Lymphangioleiomyomatosis (LAM)
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 everolim...
Detailed 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 upt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 10 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04388371
Start Date
October 18 2019
End Date
August 10 2021
Last Update
August 11 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232