Who is eligible for clinical trial NCT05676489?

Participants must meet the protocol's inclusion criteria for Healthy Volunteers. The stated age range is 18 Months to 89 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05676489 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-17

MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors (NCT05676489)

🟡 Not Yet Recruiting Early Phase1 💊 Investigational Drug / Biologic Sponsor: University of Alabama at Birmingham

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (15 items).

Location: UAB — Birmingham, Alabama

Age range: 18 Months to 89 Years

🧪 Interventions in This Study

[F-18]MeFAMP PET (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

for all cohorts:
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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria for all cohorts:
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)
Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team.
4.9.3. Inclusion criteria specific to Dosimetry Cohort
Normal complete metabolic profile (CMP) and cell blood count (CBC) with differential at baseline.
Normal ECG at baseline. Exclusion criteria specific to Dosimetry Cohort 1\) Major medical problems (e.g. renal, hepatic, inflammatory) that could interfere with biodistribution of MeFAMP as assessed by the study team. Inclusion Criteria specific to HGG Cohort
Grade III or Grade IV glioma previously treated with radiation therapy
Standard of care contrast-enhanced MRI showing an enhancing lesion at least 1-cm in maximum dimension that is equivocal or suspicious for recurrent glioma.
Eastern Cooperative Oncology Group (ECOG) performance score of 2 or better Inclusion Criteria specific to Metastasis Cohort

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

UAB — Birmingham, Alabama

📞 Contact the Study Coordinator

Phone: (205) 934-1082

Email: RadiologyCRC@uabmc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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Explore by condition: All Healthy Volunteers clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗