New brain scan agent could spot tumor recurrence vs. radiation damage
NCT ID NCT05676489
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This first-in-human study will test a new radioactive imaging agent called MeFAMP to see if it can safely and accurately detect brain tumors using PET scans. The study includes 28 people: healthy volunteers and patients with recurrent high-grade glioma or brain metastases from other cancers. The goal is to measure safety, radiation exposure, and whether MeFAMP can tell the difference between active tumor and changes caused by prior radiation therapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2027
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 months to 89 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for all cohorts: 1. 18 years of age or older at the time of enrollment 2. 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. 3. Must have a life expectancy greater than 12 weeks. Exclusion Criteria for all cohorts: 1. Use of an investigational drug for any indication within 3 months prior to the imaging study. 2. Pregnancy or breast feeding 3. Inability to complete the PET scans. 4. Significant renal or hepatic dysfunction (estimated glomerular filtration rate (GFR) \< 60 mL/min) 5. Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team. 6.4.9.3. Inclusion criteria specific to Dosimetry Cohort 1. Normal complete metabolic profile (CMP) and cell blood count (CBC) with differential at baseline. 2. 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 1. Grade III or Grade IV glioma previously treated with radiation therapy 2. 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. 3. Eastern Cooperative Oncology Group (ECOG) performance score of 2 or better Inclusion Criteria specific to Metastasis Cohort 1. At least one brain metastasis from melanoma, lung cancer (small or non-small cell), or breast cancer measuring at least 1-cm in maximum dimension on contrast-enhanced MRI 2. Plan for stereotactic radiation therapy within 2 weeks of initial MeFAMP-PET/MRI scan. 3. ECOG performance score of 2 or better Inclusion of Women and Minorities Patients 18 years of age or older will be eligible for study participation. No other discriminatory factors, including age, sex, or ethnic background will be used to determine eligibility. Every effort will be made to ensure that minorities are recruited for study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UAB
Birmingham, Alabama, 35294, United States
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