MeFAMP for Imaging System a Amino Acid Transport in Primary and Metastatic Brain Tumors

Early Phase 1

Not yet recruiting

• Conditions: Healthy Volunteers; Recurrent Glioma; Brain Metastases from Extra-cranial Solid Tumors
• Interventions: Drug: [F-18]MeFAMP PET

• Registration Number: NCT05676489
• Lead Sponsor: University of Alabama at Birmingham

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

Not available

Study Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-13
• Last Update Posted: 2024-12-18
• Study Start: 2025-12-30
• Primary Completion: 2027-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers (cohort 1)	[F-18]MeFAMP PET	Whole Body Dosimetry for healthy volunteers
High Grade Glioma (cohort 2)	[F-18]MeFAMP PET	Recurrent high grade glioma after radiation therapy
Brain Metastasis (cohort 3)	[F-18]MeFAMP PET	Brain metastases from extra-cranial solid tumors before and after radiation therapy

Primary Outcome Measures

Name	Time	Method
Safety of [F-18]MeFAMP	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.	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.
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.

Trial Locations

Locations (1)

UAB; 🇺🇸 Birmingham, Alabama, United States