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

12/20/2024
Participation Deadline: 03/31/2027
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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 and positive predictive value.
* To evaluate the added clinical usefulness of Axumin PET-CT for imaging patients with metastatic brain lesion(s).