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

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Jan 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging method called MeFAMP that helps doctors see how amino acids are transported in the brain, particularly in patients with brain tumors. The goal is to determine if this imaging technique is safe for people and to figure out how much radiation it involves. The study will include three groups of participants: healthy volunteers to assess how the imaging substance behaves in the body, patients with recurrent high-grade gliomas (a type of brain cancer), and patients with brain metastases (cancer that has spread to the brain from other parts of the body).

To participate, individuals need to be at least 18 years old and have a life expectancy of more than 12 weeks. Women who could become pregnant must have a negative pregnancy test before participating. Participants will undergo a PET scan that uses MeFAMP, which means they will be monitored closely for any potential side effects. This trial is not yet recruiting participants, but it aims to gather important data that will help improve the diagnosis and treatment of brain tumors in the future. If you are interested or think you might qualify, please consult your doctor for more information.

Gender

ALL

Eligibility 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.