MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
Qualifiers
18 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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- [F-18]MeFAMP PET
Treatment groups
28 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov