Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery
- Conditions
- Brain CancerBrain MetastasesBrain Metastases, Adult
- Interventions
- Registration Number
- NCT04689048
- Lead Sponsor
- Baptist Health South Florida
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Male or female, age ≥18 years
- Performance status, Eastern Cooperative Oncology Group 0-2
- Confirmed diagnosis of brain metastases with at least one untreated lesion >2 cm in maximum diameter
- Plan for SSRS per the treating team
- For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
- 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
- Prior anaphylactic reaction to 18F-fluciclovine
- Evidence of leptomeningeal disease
- Prior whole-brain radiation therapy
- Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
- Females pregnant at the expected time of 18F-fluciclovine administration
- 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
- Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PET/CT, MRI 18F fluciclovine In total, three 18F-fluciclovine PET/CT brain scans (pre-, interim-, and post-treatment) will be performed according to the study calendar. Generic name is Axumin and will be administered as an intravenous bolus. May administer diluted or undiluted. The maximum volume of undiluted 18F-fluciclovine is 5 mL. After administration, flush with normal saline to ensure full delivery of the dose.
- Primary Outcome Measures
Name Time Method 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.
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 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.
- Secondary Outcome Measures
Name Time Method Compare change of SUV metrics of contrast-enhanced MRI baseline To calculate the percent change in lesion volume on contrast-enhanced MRI (∆MRIvolume).
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
Trial Locations
- Locations (1)
Miami Cancer Institute
🇺🇸Miami, Florida, United States