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NCT01093612 · ClinicalTrials.gov registry record · NA
Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer
A NA study of Breast Cancer and Stage IV Breast Cancer, sponsored by City of Hope Medical Center.
- Active
- Registry status
- NA
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT01093612: Active NA study of Breast Cancer and Stage IV Breast Cancer, sponsored by City of Hope Medical Center.
NCT01093612 is a NA study of Breast Cancer and Stage IV Breast Cancer that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 18 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01093612, a NA study of Breast Cancer and Stage IV Breast Cancer, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab-labeled PET, may help doctors to plan a better treatment PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab-labeled positron emission tomography (PET) in women with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Primary Outcome
Comparison of uptake between the HER2+ and HER2- groups, treating SUVmax measurements for individual tumors as independent observations. Statistical significance of differences in SUVmax between patient groups was assessed via a nonparametric (Wilcoxon rank-sum) test. Radiolabel uptake for tumors was measured in terms of single-voxel maximum SUV (SUVmax; SUV = tissue activity per mL x body weight \[g\]/injected activity decay-corrected to time of scan).
Conditions Studied
Interventions
- PROCEDURE Biopsy
- OTHER laboratory biomarker analysis
- PROCEDURE positron emission tomography
- RADIATION copper Cu 64-DOTA-trastuzumab
- OTHER Immunohistochemistry staining method
Study Locations (1)
California
- City of Hope - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-03-16 |
| Est. Completion | 2026-09-08 |
| Phase | NA |
What the registry record for NCT01093612 still lists
NCT01093612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Biopsy is the first listed.
NCT01093612 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01093612 about?
NCT01093612 is a clinical study titled "Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer". RATIONALE: Diagnostic procedures, such as copper Cu 64-DOTA-trastuzumab-labeled PET, may help doctors to plan a better treatment PURPOSE: This pilot trial is studying copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab-labeled positron emission tomography (PET) in women with hum...
What is the current status of trial NCT01093612?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 18 participants. The study started on 2011-03-16. Estimated completion is 2026-09-08.
What conditions does trial NCT01093612 study?
This clinical trial studies the following conditions: Breast Cancer, Stage IV Breast Cancer.
What interventions are being tested in trial NCT01093612?
The interventions under investigation include: Biopsy (PROCEDURE), laboratory biomarker analysis (OTHER), positron emission tomography (PROCEDURE), copper Cu 64-DOTA-trastuzumab (RADIATION), Immunohistochemistry staining method (OTHER).
Who is sponsoring clinical trial NCT01093612?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01093612 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
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 NCT01093612's enrollment target sits among peer trials
18 1118th of 1224 higher than 97 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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