MeFAMP for Imaging Brain Tumors
This study is testing a new imaging agent called [F-18]MeFAMP, which is given before a PET scan (a type of imaging test). The goal is to see if [F-18]MeFAMP is safe and how much radiation it exposes the body to. It will also explore its use in imaging primary brain tumors (recurrent glioma) and brain tumors that have spread from other parts of the body (brain metastases). The study plans to enroll 28 participants, including healthy volunteers and patients with these types of brain tumors. The main goals are to measure the safety of [F-18]MeFAMP and how it moves through the body.
- Study design
- This is an interventional study with an unclear status, planning to enroll 28 participants across three groups: healthy volunteers, patients with recurrent glioma, and patients with brain metastases.
- What's involved
- Participants will receive [F-18]MeFAMP for a PET scan. Safety will be checked with lab tests, ECGs (heart tests), and by monitoring for side effects on the day of the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Radiation exposure will be measured from injection up to 4 hours after the PET agent is given.
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MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jonathan McConathy, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
Who to contact
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What this trial measures
- Human dosimetry for [F-18]MeFAMP.From injection to 45 minutes, 2 hours, and 4 hours after PET agent administration.
The changing concentrations of radioactivity in normal organs and tissues will be measured in each participant at 3 time points after \[F-18\]MeFAMP injection in Cohort 1. These data will be used to estimate human dosimetry as effective dose in milliSieverts.
- Safety of [F-18]MeFAMPLab values, ECG and adverse events will be assessed on the day of the study before and after administration of [F-18]MeFAMP for cohort 1.
Laboratory values including complete metabolic panel (CMP) and complete blood count with differential (CBC with diff) and adverse events will be assessed before and after \[F-18\]MeFAMP administration in cohort 1. Electrocardiograms (ECG) will also be performed before and after study drug administration in cohort 1 to assess for QT prolongation and changes in heart rate, rhythm, and ECG waveforms that could represent a safety signal due to the study drug.