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NCT03321045 · ClinicalTrials.gov registry record · Early Phase 1
Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness
A Early Phase 1 study of Breast Cancer, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03321045: Recruiting Early Phase 1 study of Breast Cancer, sponsored by University of Alabama at Birmingham.
NCT03321045 is a Early Phase 1 study of Breast Cancer that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 10 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03321045, a Early Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy.
Primary Outcome
To measure the diagnostic quality (with standardized uptake values) of PET/MRI imaging with \[89Zr\]-Df-Trastuzumab in patients with newly diagnosed breast cancer.
Conditions Studied
Interventions
- DRUG [89Zr]-Df-Trastuzumab
- DIAGNOSTIC_TEST PET/MRI Imaging
Study Locations (1)
Alabama
- The Kirklin Clinic - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2017-11-21 |
| Est. Completion | 2028-10 |
| Phase | Early Phase 1 |
What NCT03321045 shows while recruiting
NCT03321045 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 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which [89Zr]-Df-Trastuzumab is the first listed.
NCT03321045 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT03321045 about?
NCT03321045 is a clinical study titled "Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness". Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients wi...
What is the current status of trial NCT03321045?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2017-11-21. Estimated completion is 2028-10.
What conditions does trial NCT03321045 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03321045?
The interventions under investigation include: [89Zr]-Df-Trastuzumab (DRUG), PET/MRI Imaging (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03321045?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03321045 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03321045's enrollment target sits among peer trials
10 1177th of 1224 higher than 36 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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