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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05676489
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Brain Metastases From Extra-cranial Solid Tumors
  • Healthy Volunteers
  • Recurrent Glioma

Eligibility Criteria

Sex
ALL
Age
18 Months - 89 Years
Healthy Volunteers
Accepted

Interventions

  • [F-18]MeFAMP PET — DRUG
    Study 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.

Study Details

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.

Key Dates

Start date
Apr 1, 2027
Status verified
Apr 2026
Primary completion
Aug 30, 2029
Completion
Aug 30, 2029

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Healthy Volunteers (cohort 1)
    Whole Body Dosimetry for healthy volunteers
  • Experimental: High Grade Glioma (cohort 2)
    Recurrent high grade glioma after radiation therapy
  • Experimental: Brain Metastasis (cohort 3)
    Brain metastases from extra-cranial solid tumors before and after radiation therapy

Primary Outcome Measure

Human dosimetry for [F-18]MeFAMP. [ Time Frame: From injection to 45 minutes, 2 hours, and 4 hours after PET agent administration. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UABBirminghamAlabama35294
Sebastian Eady, BS
[email protected]
205-996-2636
Jonathan McConathy, MD, PhD (PRINCIPAL_INVESTIGATOR)

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UAB· Birmingham, AL

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