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64Cu DOTA-Trastuzumab Imaging for Gastric Cancer
N/A
Waitlist Available
Led By Yanghee Woo, MD
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
Either the primary tumor or at least one of the metastatic lesions must be >= 2 cm
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Must not have
Impaired cardiac function including any one of the following: complete left bundle branch block or use of a permanent cardiac pacemaker, congenital long QT syndrome, presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (< 50 beats per minute), QT interval corrected by Fridericia's formula (QTcF) > 450 msec on screening electrocardiogram (ECG), or right bundle branch block + left anterior hemiblock (bifascicular block)
Presence of atrial fibrillation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new imaging technique to study stomach cancer and help choose the best treatment.
Who is the study for?
This trial is for patients with gastric or gastroesophageal junction adenocarcinoma. Participants must have a confirmed diagnosis, certain HER2 levels, tumors >= 2 cm, an ECOG status of 0-2, and a life expectancy of at least 3 months. They should not have severe heart issues, other cancers (except skin cancer), be pregnant or breastfeeding, and must agree to use contraception.
What is being tested?
The study tests how well copper Cu 64-DOTA-trastuzumab PET/CT scans work in evaluating stomach cancer characteristics to aid treatment decisions. It's for those who haven't had recent chemotherapy, biological therapy or radiation and haven't used trastuzumab in the last six months.
What are the potential side effects?
Potential side effects may include allergic reactions to the tracer substance used in imaging (copper Cu 64-DOTA-trastuzumab), discomfort from PET/CT procedures such as needle insertion for IVs and lying still during scanning.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a tumor or lesion that is at least 2 cm large.
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I am able to get out of my bed or chair and move around.
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My heart pumps blood normally.
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My cancer is strongly HER2 positive as confirmed by specific tests.
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I have been diagnosed with cancer in my stomach or where my stomach meets my esophagus.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a heart condition such as irregular heartbeat or need a pacemaker.
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I have atrial fibrillation.
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I have had chest pain or a heart attack in the last 6 months.
Select...
I have severe heart failure.
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I do not have any active infections or cancer, except possibly skin cancer.
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I haven't had any cancer treatment like chemo or radiation yet.
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My blood pressure is not higher than 160/90.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of HER2 Negative, Positive, or Equivocal Participants With Either Negative or Positive Tumor Readings
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)Experimental Treatment4 Interventions
Patients receive copper Cu 64-DOTA-trastuzumab IV on day 1 and then undergo PET/CT scan on days 2 or 3.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
positron emission tomography
2010
Completed Phase 2
~1370
Computed Tomography
2017
Completed Phase 2
~2790
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,439 Total Patients Enrolled
Yanghee Woo, MDPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a heart condition such as irregular heartbeat or need a pacemaker.I have atrial fibrillation.I have had chest pain or a heart attack in the last 6 months.I have severe heart failure.I do not have any active infections or cancer, except possibly skin cancer.My cancer has a tumor or lesion that is at least 2 cm large.I am able to get out of my bed or chair and move around.I am not pregnant, will test before the study, and will use birth control during and for four months after the study.My heart pumps blood normally.All my side effects from previous treatments have mostly gone away.I haven't had any cancer treatment like chemo or radiation yet.I haven't taken trastuzumab in the last 6 months.My cancer is strongly HER2 positive as confirmed by specific tests.My blood pressure is not higher than 160/90.I have been diagnosed with cancer in my stomach or where my stomach meets my esophagus.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.