NCT05676489Not yet recruitingEarly phase 1
MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 28 (estimated)
- First submitted
- 12 Dec 2022
- Start date
- 1 Apr 2027
- Primary completion date
- 30 Aug 2029
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Childhood cancers
- NCT number
- NCT05676489
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 28
- From 1 Apr 2027 to the primary completion date, 30 Aug 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of an investigational drug for any indication within 3 months prior to the imaging study.
Other illness
- 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
Lab values
- Significant renal or hepatic dysfunction (estimated glomerular filtration rate (GFR) \< 60 mL/min)
- Normal complete metabolic profile (CMP) and cell blood count (CBC) with differential at baseline.
Other
- Pregnancy or breast feeding
- Inability to complete the PET scans.
- 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.
Who the study is looking for
- 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
- 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
- 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.
Age in the registry: 18 months to 89 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UAB Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.