MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
Status:
Not yet recruiting
Trial end date:
2026-08-30
Target enrollment:
Participant gender:
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.