This early phase I trial tests the safety and dosing of [18F]MeFAMP for patients with high grade glioma (HGG) or melanoma, lung or breast cancer that has spread (metastatic) to the brain. [18F]MeFAMP is an amino acid with a radioactive portion call fluorine-18 [18F]. This drug enters normal and tumor cells through a system of amino acid transport which recognizes amino acids normally present in the blood. This then allows the positron emission tomography (PET) scan to distinguish healthy and tumor tissue. [18F]MeFAMP may work better in imaging patients with glioma, melanoma, lung or breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05676489.
Locations matching your search criteria
United States
Alabama
Birmingham
University of Alabama at Birmingham Cancer CenterStatus: Active
Contact: Jonathan E. McConathy
Phone: 205-934-1388
PRIMARY OBJECTIVES:
I. Establish the safety and feasibility of [18F]MeFAMP for human PET imaging.
II. Estimate the human dosimetry of [18F]MeFAMP.
EXPLORATORY OBJECTIVES:
I. Obtain preliminary data regarding the uptake of [18F]MeFAMP in high grade gliomas, metastatic brain tumors, pseudoprogression and radiation necrosis.
II. Determine if [18F]MeFAMP identifies additional sites of tumor involvement in the brain not prospectively identified by standard of care magnetic resonance imaging (MRI).
OUTLINE: Participants are assigned to 1 of 3 cohorts.
DOSIMETRY COHORT: Participants receive [18F]MeFAMP intravenously (IV), over approximately 30 seconds, and undergo whole body PET/computed tomography (CT) scan at 15 minutes, 45 minutes, 2 hours and 4 hours after injection. Participants also undergo blood sample collection throughout the study.
HGG COHORT: Patients receive [18F]MeFAMP IV, over approximately 30 seconds, and undergo dynamic PET/MRI over 60 minutes and static PET/MRI over 20 minutes. Patients also undergo blood sample collection throughout the study.
METASTASIS COHORT: Patients receive [18F]MeFAMP IV, over approximately 30 seconds, and undergo dynamic PET/MRI over 60 minutes and static PET/MRI over 20 minutes within 2 weeks prior to standard of care (SOC) radiation therapy and within 2-3 months after completing SOC radiation therapy. Patients also undergo blood sample collection throughout the study.
After completion of study treatment, participants in the Dosimetry Cohort are followed up at 24-48 hours, and patients in the HGG and Metastasis Cohorts are followed up at 24-48 hours and 1 year.
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorJonathan E. McConathy
