Healthy VolunteersEarly Phase 1NCT05676489
MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
A Early Phase 1 study testing [F-18]MeFAMP PET in people with Healthy Volunteers and Recurrent Glioma, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Recurrent Glioma, Brain Metastases From Extra-cranial Solid Tumors
- What is being tested?
- [F-18]MeFAMP PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 30 Aug 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 89 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- 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
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- 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
- Plan for stereotactic radiation therapy within 2 weeks of initial MeFAMP-PET/MRI scan.
- ECOG performance score of 2 or better
- 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.
Who cannot join
- 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.
- 6.4.9.3. Inclusion criteria specific to Dosimetry Cohort
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- Normal complete metabolic profile (CMP) and cell blood count (CBC) with differential at baseline.
- Normal ECG at baseline.
- 1) Major medical problems (e.g. renal, hepatic, inflammatory) that could interfere with biodistribution of MeFAMP as assessed by the study team.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UAB
Birmingham, Alabama, 35294
Sebastian Eady, BS, 205-996-2636, radiologyCRC@uabmc.edu
Jonathan McConathy, MD, PhD
About this study
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.
- Being tested
- [F-18]MeFAMP PET
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]MeFAMP PETDrug
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 group | Role | What they receive |
|---|---|---|
| Healthy Volunteers (cohort 1) | Experimental | Whole Body Dosimetry for healthy volunteers Receives: Drug: [F-18]MeFAMP PET |
| High Grade Glioma (cohort 2) | Experimental | Recurrent high grade glioma after radiation therapy Receives: Drug: [F-18]MeFAMP PET |
| Brain Metastasis (cohort 3) | Experimental | Brain metastases from extra-cranial solid tumors before and after radiation therapy Receives: Drug: [F-18]MeFAMP PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Human dosimetry for [F-18]MeFAMP.
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.
Measured: From injection to 45 minutes, 2 hours, and 4 hours after PET agent administration.
Safety of [F-18]MeFAMP
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Apr 2027 (estimated)
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Hensley, University of Alabama at Birmingham
- Investigators
- Jonathan McConathy, MD, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676489
- Sponsor's protocol ID
- IRB-300009933 R22-225
- Status last verified
- Aug 2026
- First submitted
- 12 Dec 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
- ClinicalTrials.gov ID
- NCT05676489
- Acronym / sponsor ID
- IRB-300009933 R22-225
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers (cohort 1) | Experimental | Drug: [F-18]MeFAMP PETWhole Body Dosimetry for healthy volunteers |
| High Grade Glioma (cohort 2) | Experimental | Drug: [F-18]MeFAMP PETRecurrent high grade glioma after radiation therapy |
| Brain Metastasis (cohort 3) | Experimental | Drug: [F-18]MeFAMP PETBrain metastases from extra-cranial solid tumors before and after radiation therapy |
Who may qualify
- Ages
- 18 months to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [F-18]MeFAMP PETStudy 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. | Drug | Brain Metastasis (cohort 3), Healthy Volunteers (cohort 1), High Grade Glioma (cohort 2) |
Primary outcome
Human dosimetry for [F-18]MeFAMP.
Time frame: 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.
Safety of [F-18]MeFAMP
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan McConathy, MD, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [F-18]MeFAMP PET in people with Healthy Volunteers and Recurrent Glioma, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Eady, BS (205-934-1082, RadiologyCRC@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.