MeFAMP for Imaging System A Amino Acid Transport in Primary and Metastatic Brain Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Months - 89 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05676489
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Early Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Alabama at Birmingham
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jonathan McConathy, MD, PhD
Principal Investigator Affiliation	University of Alabama at Birmingham
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Healthy Volunteers, Recurrent Glioma, Brain Metastases From Extra-cranial Solid Tumors

Arms & Interventions

Arms

Experimental: Healthy Volunteers (cohort 1)

Whole Body Dosimetry for healthy volunteers

Experimental: High Grade Glioma (cohort 2)

Recurrent high grade glioma after radiation therapy

Experimental: Brain Metastasis (cohort 3)

Brain metastases from extra-cranial solid tumors before and after radiation therapy

Interventions

Drug: - [F-18]MeFAMP PET

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UAB, Birmingham, Alabama

Status

Address

UAB

Birmingham, Alabama, 35294

Site Contact

Sebastian Eady, BS

[email protected]

205-996-2636