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PET Scan with Copper Cu 64-DOTA-Trastuzumab for Breast Cancer
N/A
Waitlist Available
Led By Joanne Mortimer
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours after injection of 64 cu-dota-trastuzumab
Awards & highlights
Study Summary
This trial is looking at using copper Cu 64-DOTA-trastuzumab-labeled PET to help plan better treatment for women with HER2-positive breast cancer.
Who is the study for?
This trial is for women with advanced HER2-positive breast cancer that has spread beyond the original tumor and axilla. They must have a biopsy confirming metastasis, not received trastuzumab in the last 2 months, and have at least one non-liver metastatic site over 2 cm. Participants need normal heart function and can't be pregnant or unable to consent.Check my eligibility
What is being tested?
The study tests a PET scan using copper Cu 64-DOTA-trastuzumab to see if it helps plan better treatments for breast cancer. It includes laboratory biomarker analysis, immunohistochemistry staining method, mutation analysis, and biopsies to assess the cancer's characteristics.See study design
What are the potential side effects?
While specific side effects are not listed for this diagnostic trial, potential risks may include reactions to tracers used in PET scans such as discomfort or bruising from injections, allergic reactions or exposure to radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours after injection of 64 cu-dota-trastuzumab
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours after injection of 64 cu-dota-trastuzumab
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tumor Uptake of 64Cu-DOTA-trastuzumab After 24 Hours
Tumor Uptake of 64Cu-DOTA-trastuzumab After 48 Hours
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm IExperimental Treatment6 Interventions
PART ONE: Patients are randomized to 1 of 3 dose levels. Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab. PART TWO: Patients undergo a PET scan 24-48 hours after injection of copper Cu 64-DOTA-trastuzumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
positron emission tomography
2010
Completed Phase 2
~1370
mutation analysis
2002
Completed Phase 2
~3190
Biopsy
2014
Completed Phase 4
~850
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Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,442 Total Patients Enrolled
42 Trials studying Breast Cancer
6,631 Patients Enrolled for Breast Cancer
Joanne MortimerPrincipal InvestigatorCity of Hope Medical Center
6 Previous Clinical Trials
157 Total Patients Enrolled
Media Library
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies still available for prospective participants in this research?
"As per data hosted on clinicaltrials.gov, this medical study is not currently recruiting. This trial was initially published in March of 2011 and most recently updated in August 2022, with 2607 other studies presently enrolling patients at this time."
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