MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors

Trial Title: MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors

NCT ID: NCT05676489

Condition: Healthy Volunteers
Recurrent Glioma
Brain Metastases From Extra-cranial Solid Tumors

Conditions: Official terms:
Brain Neoplasms

Study type: Interventional

Study phase: Early Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: [F-18]MeFAMP PET
Description: Study participants will receive the fluorine-18 labeled system A amino acid transport substrate, (R)-3-[F-18]fluoro-2-methyl-2-(methylamino)propanoic acid ([F-18]MeFAMP), for positron emission tomography (PET). Participants in Cohorts 1 and 2 will receive a single administration of the study drug. Participants in cohort 3 will receive 2 administrations of the study drug, once before standard of care radiation therapy for brain metastases and once after.
Arm group label: Brain Metastasis (cohort 3)
Arm group label: Healthy Volunteers (cohort 1)
Arm group label: High Grade Glioma (cohort 2)

Summary: This first-in-human study will establish the human safety and radiation dosimetry of the system A amino acid transport substrate, (R)-3-[F-18]fluoro-2-methyl-2-(methylamino)propanoic acid ([F-18]MeFAMP), for positron emission tomography (PET) imaging of primary and metastatic brain tumors. This study will include 3 cohorts: healthy volunteers for whole body dosimetry estimates (n=6-8, Dosimetry Cohort), patients undergoing evaluation for recurrent high grade glioma after radiation therapy (n=10, high grade glioma (HGG) Cohort), and patients with brain metastases from extra-cranial solid tumors before and after radiation therapy (n=10, Metastasis Cohort). Exploratory assessment of the diagnostic accuracy of MeFAMP for distinguishing recurrent/progressive brain tumors from radiation-related treatment effects will also be performed for subsequent trial design. The study will complete accrual and safety assessment in the Dosimetry Cohort before recruiting for the HGG and Metastasis Cohorts.

Criteria for eligibility:
Criteria:
Inclusion Criteria for all cohorts: 1. 18 years of age or older at the time of enrollment 2. Females with childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test on the day of procedure or a serum hCG test within 48 hours prior to the administration MeFAMP. 3. Must have a life expectancy greater than 12 weeks. Exclusion Criteria for all cohorts: 1. Use of an investigational drug for any indication within 3 months prior to the imaging study. 2. Pregnancy or breast feeding 3. Inability to complete the PET scans. 4. Significant renal or hepatic dysfunction (estimated glomerular filtration rate (GFR) < 60 mL/min) 5. Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team. 6.4.9.3. Inclusion criteria specific to Dosimetry Cohort 1. Normal complete metabolic profile (CMP) and cell blood count (CBC) with differential at baseline. 2. Normal ECG at baseline. Exclusion criteria specific to Dosimetry Cohort 1) Major medical problems (e.g. renal, hepatic, inflammatory) that could interfere with biodistribution of MeFAMP as assessed by the study team. Inclusion Criteria specific to HGG Cohort 1. Grade III or Grade IV glioma previously treated with radiation therapy 2. Standard of care contrast-enhanced MRI showing an enhancing lesion at least 1-cm in maximum dimension that is equivocal or suspicious for recurrent glioma. 3. Eastern Cooperative Oncology Group (ECOG) performance score of 2 or better Inclusion Criteria specific to Metastasis Cohort 1. At least one brain metastasis from melanoma, lung cancer (small or non-small cell), or breast cancer measuring at least 1-cm in maximum dimension on contrast-enhanced MRI 2. Plan for stereotactic radiation therapy within 2 weeks of initial MeFAMP-PET/MRI scan. 3. ECOG performance score of 2 or better Inclusion of Women and Minorities Patients 18 years of age or older will be eligible for study participation. No other discriminatory factors, including age, sex, or ethnic background will be used to determine eligibility. Every effort will be made to ensure that minorities are recruited for study participation.

Gender: All

Minimum age: 18 Months

Maximum age: 89 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: UAB

Address:
City: Birmingham
Zip: 35294
Country: United States

Contact:
Last name: Sebastian Eady, BS

Phone: 205-996-2636
Email: radiologyCRC@uabmc.edu

Investigator:
Last name: Jonathan McConathy, MD, PhD
Email: Principal Investigator

Start date: December 30, 2024

Completion date: August 30, 2026

Lead sponsor:
Agency: University of Alabama at Birmingham
Agency class: Other

Source: University of Alabama at Birmingham

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05676489