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An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis

StatusRecruiting
PhasePhase 4
Started2022-12-21
View on ClinicalTrials.gov ↗

Amendment history

2026-06-29
Study Status v8
Primary completion pushed: 2026-05-26 → 2027-04-27
Completion pushed: 2026-05-26 → 2027-04-27
2026-02-20
Study Status v7
Primary completion date2026-02-25→2026-05-26
Completion date2026-02-25→2026-05-26
2025-02-17
Study Status v6
Re-verified, no change to tracked fields
2024-02-15
Study Status v5
Primary completion date2025-02-25→2026-02-25
Completion date2025-02-25→2026-02-25
2023-02-14
Study Status v4
Primary completion date2023-08-02→2025-02-25
Completion date2023-08-02→2025-02-25
Start dateestimated 2023-01-16→confirmed 2022-12-21
Show 3 earlier versions
2022-11-22
Study Status v3
Start date2022-10-16→2023-01-16
2022-08-30
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2022-08-16→2022-10-16
Study sitesdetails revised at 1 of 1 site
2022-07-06
Study Status v1
Start date2022-06-16→2022-08-16
2022-05-11
Original filing
This clinical trial examines an investigational scan (64Cu-DOTA-trastuzumab positron emission tomography \[PET\]/magnetic resonance imaging \[MRI\]) in imaging patients with HER2+ breast cancer that has spread to the brain (brain metastasis). Diagnostic procedures, such as 64Cu-DOTA-trastuzumab PET/MRI, may help find HER2+ breast cancer that has spread to the brain and determine whether cancer in the brain takes up trastuzumab, which may predict for response to trastuzumab deruxtecan (the standard of care chemotherapy).
Trial Details
NCT Number NCT05376878
Lead Sponsor City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Conditions Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain
Enrollment 10 participants
Start Date 2022-12-21
Primary Completion 2027-04-27 (estimated)
Study Completion 2027-04-27 (estimated)
Updated on ClinicalTrials.gov 2026-07-01