Brain Cancer, Brain Metastases, Brain Metastases, Adult
Conditions
Keywords
brain, brain metastases, brain metastases, adult, brain cancer, Stereotactic Radiosurgery
Brief summary
The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.
Interventions
DRUG18F fluciclovine
Patients will receive a standard 5 millicuries dose of 18F-fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-fluciclovine immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.
Sponsors
Baptist Health South Florida
Blue Earth Diagnostics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a prospective, single-site, single-arm, phase 1 proof-of-concept study to assess the potential clinical utility of 18F-fluciclovine PET/CT as a functional integral biomarker for patients with large brain metastases (\>2 cm) treated with Staged Stereotactic Radiosurgery (SSRS).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, age ≥18 years 2. Performance status, Eastern Cooperative Oncology Group 0-2 3. Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter 4. Plan for SSRS per the treating team 5. For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required 6. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-fluciclovine positron emission tomography/computerized tomography
Exclusion criteria
1. Prior anaphylactic reaction to 18F-fluciclovine 2. Evidence of leptomeningeal disease 3. Prior whole-brain radiation therapy 4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker) 5. Females pregnant at the expected time of 18F-fluciclovine administration 6. Females who are expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed 7. Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sensitivity for PET/CT | through study completion, an average of 1 year | Calculate the sensitivity of pre-treatment 18F-fluciclovine PET/CT to identify brain metastases \>2 cm treated with SSRS. |
| Change in sensitivity for MRI | through study completion, an average of 1 year | To calculate the sensitivity of pre-treatment contrast-enhanced MRI. |
| Change in the standardized uptake value (SUV) parameters | through study completion, an average of 1 year | To identify a change in the standardized uptake value (SUV) parameters (SUVpeak, SUVmean, and SUVmax) for the 18F-fluciclovine PET/CT scans. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare change of SUV metrics of 18F-fluciclovine PET | baseline | To calculate the pre-, interim-, and post-treatment SUV metrics of 18F-fluciclovine PET uptake |
| Compare change of SUV metrics of contrast-enhanced MRI | baseline | To calculate the percent change in lesion volume on contrast-enhanced MRI (∆MRIvolume). |
Countries
United States
Contacts
CONTACTRupesh C Kotecha, MD
CONTACTKristy Reyes
PRINCIPAL_INVESTIGATORRupesh R Kotecha, MD
Miami Cancer Institute (MCI) at Baptist Health, Inc.
Outcome results
None listed