18F-Fluciclovine Imaging for Brain Tumors
(CONCORDANT Trial)
Trial Summary
What is the purpose of this trial?
This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.
What data supports the idea that 18F-Fluciclovine Imaging for Brain Tumors is an effective treatment?
The available research shows that 18F-Fluciclovine is effective in detecting brain tumors, especially in cases where other imaging methods like MRI have limitations. It has been shown to identify tumor regions that conventional MRI scans might miss. Studies also indicate that 18F-Fluciclovine is useful in assessing recurrent brain tumors and provides better regional assessment of tumor activity compared to some other imaging techniques. This suggests that 18F-Fluciclovine can be a valuable tool in managing brain tumors by offering more detailed information about the tumor's presence and activity.12345
What safety data is available for 18F-Fluciclovine in brain tumor imaging?
Is the drug 18F-Fluciclovine a promising treatment for brain tumors?
Research Team
Rupesh R Kotecha, MD
Principal Investigator
Miami Cancer Institute/Baptist Health South Florida
Eligibility Criteria
This trial is for adults over 18 who've had brain surgery to remove metastasis and are set for follow-up radiosurgery. They must be in a stable enough condition (ECOG 0-3) and agree to use two effective contraception methods if of reproductive potential. It's not for those with prior whole-brain radiation, MRI contraindications, pregnancy during the study period, breastfeeding without pausing it post-imaging, previous severe reaction to 18F-Fluciclovine or leptomeningeal disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-surgery Imaging
Optional pre-surgery 18F-Fluciclovine PET/CT scan to evaluate the extent of surgery
SRS Treatment Planning
18F-Fluciclovine PET/CT scan in addition to planning MRI at the time of SRS treatment
Follow-up
Participants undergo routine follow-up with 18F-Fluciclovine PET/CT and MRI to monitor resection beds for tumor control and detect patterns of failure
Treatment Details
Interventions
- 18F-Fluciclovine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baptist Health South Florida
Lead Sponsor
Blue Earth Diagnostics
Industry Sponsor