Trial Summary
What is the purpose of 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
This trial is for adults over 18 with a life expectancy of more than 12 weeks. It includes healthy volunteers, those with high-grade glioma after radiation, and patients with brain metastases from other tumors. Women able to have children must test negative for pregnancy.Inclusion Criteria
You are expected to live for more than 12 weeks.
Women who could become pregnant must have a negative pregnancy test before the procedure.
I am 18 years old or older.
Participant Groups
[F-18]MeFAMP PET imaging is being tested to see if it's safe and how well it can show primary and metastatic brain tumors. The study has three parts: one for healthy people, one for glioma patients, and another for those with brain metastases.
3Treatment groups
Experimental Treatment
Group I: High Grade Glioma (cohort 2)Experimental Treatment1 Intervention
Recurrent high grade glioma after radiation therapy
Group II: Healthy Volunteers (cohort 1)Experimental Treatment1 Intervention
Whole Body Dosimetry for healthy volunteers
Group III: Brain Metastasis (cohort 3)Experimental Treatment1 Intervention
Brain metastases from extra-cranial solid tumors before and after radiation therapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UABBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor