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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

StatusTerminated
PhaseNot applicable
Started2024-11-07
View on ClinicalTrials.gov ↗

Amendment history

2026-09-24
critical
Trial terminated: \<\&%% participation
Primary completion confirmed: September 2026 (last estimated March 2028)
2026-06-01
critical
Study Status, Study Design, Contacts/Locations v6
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment reduced: 20 → 3 participants
Study sitesdetails revised at 1 of 1 site
2026-04-10
minor
2 amendments v4-v5
2 re-verifications since 2025-10-23, no change to tracked fields
2025-05-12
minor
Study Status v3
Primary completion date2025-03-31→2028-03-30
Completion date2027-03-31→2028-03-30
2024-11-18
minor
Study Identification, Study Status v2
Re-verified, no change to tracked fields
2024-11-15
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-02-28→confirmed 2024-11-07
Study sitesdetails revised at 1 of 1 site
2023-08-23
minor
Original filing
To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy.
Trial Details
NCT Number NCT06015295
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Blue Earth Diagnostics
Conditions Brain Metastases
Enrollment 3 participants
Start Date 2024-11-07
Primary Completion 2026-09-17 (estimated)
Study Completion 2026-09-17 (estimated)
Updated on ClinicalTrials.gov 2026-09-23