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New brain scan agent could spot tumor recurrence vs. radiation damage

NCT ID NCT05676489

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2027

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

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

18 months to 89 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • UAB

    Birmingham, Alabama, 35294, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.