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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
[F-18]MeFAMP PET
DrugStudy participants will receive the fluorine-18 labeled 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). Participants in Cohorts 1 and 2 will receive a single administration of the study drug. Participants in cohort 3 will receive 2 administrations of the study drug, once before standard of care radiation therapy for brain metastases and once after.
Treatment groups
28 Participants
are divided into 3 treatment groupsGroup A: Healthy Volunteers (cohort 1)Experimental treatment 1 intervention
Group B: High Grade Glioma (cohort 2)Experimental treatment 1 intervention
Group C: Brain Metastasis (cohort 3)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Human dosimetry for [F-18]MeFAMP.
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.
Time frame
From injection to 45 minutes, 2 hours, and 4 hours after PET agent administration.2
Safety of [F-18]MeFAMP
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.
Time frame
Lab 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.Sponsors and contacts
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Source ClinicalTrials.gov
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