Glutamine PET Imaging in LAM

NCT04388371 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 190481
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Lymphangioleiomyomatosis (LAM)

Outcome Measures

Primary Outcomes (1)

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

  While these imaging techniques have not been used in normal populations, the pulmonary uptake of patients with known intraabdominal malignancy will serve as control for evaluation of any potential uptake. When comparing treatment effects, each patient can serve as their own control as they will have already had imaging completed prior to the initiation of therapy. VEGF-D levels will be collected from clinical laboratory assessment or will be collected at time of enrollment, and relative elevation of VEGF-D will be compared to the relative uptake of tracer within the pulmonary parenchyma of each individual patient.

  8 weeks

Study Arms (2)

Prior to subject taking sirolimus or everolimus

EXPERIMENTAL

To compare images from subjects prior to use of sirolimus or everolimus to images produced after use of sirolimus or everolimus.

Drug: Glutamine

subjects taking sirolimus or everolimus

EXPERIMENTAL

To compare images from subjects prior to use of sirolimus or everolimus to images produced after use of sirolimus or everolimus.

Drug: Glutamine

Interventions

Glutamine DRUG

Glutamine will be administered by IV injection prior to PET imaging.

Prior to subject taking sirolimus or everolimus; subjects taking sirolimus or everolimus

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Because LAM is a disease that occurs essentially only in females, the study population will consist of only females.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• The LAM Foundation: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Lymphangioleiomyomatosis

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Lymphangiomyoma; Neoplasm, Lymphatic Tissue; Neoplasms by Histologic Type; Neoplasms; Perivascular Epithelioid Cell Neoplasms; Neoplasms, Connective and Soft Tissue; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Timothy S Blackwell, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Test 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.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: October 18, 2019
• Primary Completion: June 30, 2021
• Study Completion: August 10, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)