Spots Global Cancer Trial Database for MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
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Trial Identification
Brief Title: MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
Official Title: MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
Study ID: NCT05676489
Interventions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Months
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
UAB, Birmingham, Alabama, United States
Contact Details
Name: Jonathan McConathy, MD, PhD
Affiliation: University of Alabama at Birmingham
Role: PRINCIPAL_INVESTIGATOR
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