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Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery

StatusRecruiting
PhasePhase 1
Started2022-04-04
View on ClinicalTrials.gov ↗

Amendment history

2026-04-20
critical
Study Status v15
Primary completion pushed: 2026-03 → 2027-03
Completion pushed: 2026-12 → 2027-12
2026-02-13
minor
Study Status v14
Primary completion date2025-12→2026-03
2025-09-19
minor
Study Status, Contacts/Locations v13
Study sitescontacts updated at 1 of 1 site
2025-01-16
minor
Study Status v12
Primary completion date2024-12→2025-12
Completion date2025-12→2026-12
2024-10-17
minor
Study Status, Contacts/Locations v11
Study sitescontacts updated at 1 of 1 site
Show 10 earlier versions
2023-12-26
minor
Study Status, Contacts/Locations v10
Study sites2→1
2023-10-27
minor
Study Status v9
Re-verified, no change to tracked fields
2022-11-18
minor
Study Status v8
Primary completion date2022-12→2024-12
Completion date2023-12→2025-12
Start date2021-11-15→2022-04-04
2022-04-11
minor
Study Status, Contacts/Locations v7
Re-verified, no change to tracked fields
2022-02-21
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-12-01→confirmed 2021-11-15
Study sites1→2
2021-10-29
minor
Study Status v5
Primary completion date2021-12→2022-12
Completion date2022-12→2023-12
Start date2021-09→2021-12-01
2021-07-13
minor
Study Status v4
Re-verified, no change to tracked fields
2021-06-10
minor
Study Status v3
Start date2021-05→2021-09
2021-05-11
minor
Study Status, Study Design v2
Enrollment target10→20
2021-01-12
minor
Study Status v1
Start date2020-12→2021-05
2020-12-28
minor
Original filing
The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.
Trial Details
NCT Number NCT04689048
Lead Sponsor Baptist Health South Florida
Collaborators: Blue Earth Diagnostics
Conditions Brain Metastases, Adult, Brain Metastases, Brain Cancer
Enrollment 20 participants
Start Date 2022-04-04
Primary Completion 2027-03 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-22