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NCT05376878 · ClinicalTrials.gov registry record · Phase 4
An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis
A Phase 4 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05376878: Recruiting Phase 4 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, sponsored by City of Hope Medical Center.
NCT05376878 is a Phase 4 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 10 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05376878, a Phase 4 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
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).
Primary Outcome
Percentage of patient with quantifiable 64Cu-DOTA-trastuzumab PET imaging (maximum standardized uptake value\[SUVmax\]) uptake in brain lesions.
Conditions Studied
Interventions
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Trastuzumab
- OTHER Copper Cu 64-DOTA-Trastuzumab
- DEVICE Positron Emission Tomography
- BIOLOGICAL Trastuzumab Deruxtecan
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-12-21 |
| Est. Completion | 2026-05-26 |
| Phase | Phase 4 |
What NCT05376878 shows while recruiting
NCT05376878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT05376878 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05376878 about?
NCT05376878 is a clinical study titled "An Investigational Scan (64Cu-DOTA-Trastuzumab PET/MRI) in Imaging Patients With HER2+ Breast Cancer With Brain Metastasis". 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/...
What is the current status of trial NCT05376878?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2022-12-21. Estimated completion is 2026-05-26.
What conditions does trial NCT05376878 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Breast Carcinoma.
What interventions are being tested in trial NCT05376878?
The interventions under investigation include: Magnetic Resonance Imaging (PROCEDURE), Trastuzumab (BIOLOGICAL), Copper Cu 64-DOTA-Trastuzumab (OTHER), Positron Emission Tomography (DEVICE), Trastuzumab Deruxtecan (BIOLOGICAL).
Who is sponsoring clinical trial NCT05376878?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05376878 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05376878's enrollment target sits among peer trials
10 57th of 59 higher than 3 of 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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