Brain Metastases From Extra-cranial Solid Tumors, Healthy Volunteers, Recurrent Glioma
Conditions
Brief 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. 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.
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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 89 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human dosimetry for [F-18]MeFAMP. | 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 | 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. |
Countries
United States
Contacts
CONTACTSebastian Eady, BS
PRINCIPAL_INVESTIGATORJonathan McConathy, MD, PhD
University of Alabama at Birmingham
Outcome results
None listed