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
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