NCT05676489
MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
Not Yet Recruiting · Early Phase 1 · University of Alabama at Birmingham · registry updated 2026-08-20
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Inclusion Criteria for all cohorts:
- years of age or older at the time of enrollment
- 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.
- Must have a life expectancy greater than 12 weeks.
Exclusion
- Exclusion Criteria for all cohorts:
- Use of an investigational drug for any indication within 3 months prior to the imaging study.
- Pregnancy or breast feeding
- Inability to complete the PET scans.
- Significant renal or hepatic dysfunction (estimated glomerular filtration rate (GFR) \< 60 mL/min)
- Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team.