NCT06015295

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Brain Metastases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	18F-Fluciclovine (Axumin)	Given by Injection
DIAGNOSTIC_TEST	Pet Scan	Scans

Timeline

• Start date: 2024-11-07
• Primary completion: 2028-03-30
• Completion: 2028-03-30
• First posted: 2023-08-29
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States