A Pilot Study to Assess the Clinical Utility of 18F-Fluciclovine (Axumin) PET-CT for Detecting True-versus Pseudo-Progression of Brain Metastases on Immunotherapy
M.D. Anderson Cancer Center
Summary
To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy.
Description
Primary Objective: * To assess the diagnosis accuracy of 18F-Fluciclovine (Axumin) PET-CT in detecting true- versus pseudo-progression of brain metastatic lesions in patients on immunotherapy. Accuracy is defined as the number of concordant cases between Axumin PET-CT and the gold standard truth divided by the total sample size. Secondary Objectives * To assess diagnosis accuracy of Axumin PET-CT in detecting true- versus pseudo-progression of brain metastatic lesions in patients on immunotherapy by additional accuracy measures including sensitivity, specificity, negative predictive value…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of Axumin in pediatric patients, patients \<18 years of age are excluded from this study. 2. ECOG performance status ≤2 (Karnofsky ≥60%,). 3. Willingness to participate in the study and ability to provide written informed consent. 4. Patients must have documented brain metastatic lesion(s) in the medical record. 5. On active immunotherapy for the diagnosed malignancy. Concurrent other treatment is allowed. Immunotherapy and other treatment regimens are determined by treating physic…
Interventions
- Diagnostic Test18F-Fluciclovine (Axumin)
Given by Injection
- Diagnostic TestPet Scan
Scans
Location
- M D Anderson Cancer CenterHouston, Texas