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NOT YET RECRUITING

NCT05676489

EARLY_PHASE1

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

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Months - 89 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-01

Completion Date

2027-08-30

Last Updated

2026-02-20

Healthy Volunteers

Yes

Conditions

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

Interventions

DRUG

[F-18]MeFAMP PET

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.

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.

Locations (1)

UAB

Birmingham, Alabama, United States