Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis (CONCORDANT)

NCT05554302 Phase 2 RECRUITING

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.

Details

Lead sponsor	Baptist Health South Florida
Phase	Phase 2
Status	RECRUITING
Enrolment	20
Start date	2023-01-10
Completion	2030-01

Conditions

• Brain Metastases
• Brain Cancer

Interventions

• 18F-Fluciclovine

Primary outcomes

• Change in conformality index of tumor target volume delineation — 3 weeks, 6 and 12 months
  The tumor target volume (post-operative cavity and any residual or recurrent disease) will be delineated by post-operative MRI only. A second target volume will be generated using the 18F-Fluciclovine PET-defined volume. The conformality index is calculated by comparing the PET-defined tumor volume with MRI-defined tumor volume. Non-overlapping and overlapping regions regions of PET tumor volume and MRI tumor volume will be used to calculate conformality indices.
• Change in PET scan standardized uptake value (SUV) parameters — 3 weeks, 6 and 12 months
  The standardized uptake value (SUV) parameters of SUVpeak, SUVmean, and SUVmax will be measured to determine if they correlate tumor volume and can predict risk of recurrence.

Countries

United States