64Cu DOTA-Trastuzumab PET/CT in Studying Patients With Gastric Cancer
NCT ID: NCT01939275
Last Updated: 2025-02-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2014-11-19
2024-08-05
Brief Summary
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Detailed Description
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I. To compare tumor uptake of 64Cu-DOTA-trastuzumab (copper Cu 64-DOTA-trastuzumab) in gastric cancer patients with pathologic evaluation of tumor human epidermal growth factor receptor 2 (HER2)/neu expression.
II. To compare copper Cu 64-DOTA-trastuzumab-PET-CT scan with standard radiographic imaging for staging patients with gastric cancer.
OUTLINE:
Patients receive copper Cu 64-DOTA-trastuzumab intravenously (IV) on day 1 and then undergo PET/CT scan on days 2 or 3.
After completion of study, patients are followed up for 15 days and periodically for up to 6 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (copper Cu 64-DOTA-trastuzumab PET scan)
Patients receive copper Cu 64-DOTA-trastuzumab IV on day 1 and then undergo PET/CT scan on days 2 or 3.
copper Cu 64-DOTA-trastuzumab
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
positron emission tomography
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
laboratory biomarker analysis
Correlative studies
Computed Tomography
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
Interventions
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copper Cu 64-DOTA-trastuzumab
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
positron emission tomography
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
laboratory biomarker analysis
Correlative studies
Computed Tomography
Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Two patients must be HER2 3+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) positive
* 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
* Life expectancy of \>= 3 months
* Women of childbearing potential must have a negative serum pregnancy test within 14 days of copper Cu 64-DOTA administrations and must have agreed to use an effective contraceptive method; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for four months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
* CT/magnetic resonance imaging (MRI) scan must be obtained within 4 weeks prior to study entry
* Patients must have normal cardiac ejection fraction
* All subjects must have the ability to understand and the willingness to sign a written informed consent
* All toxicities should recover to grade 0 or 1 prior to day 1
Exclusion Criteria
* Presence of atrial fibrillation
* Previous history of angina pectoris or acute myocardial infarction (MI) within 6 months
* Congestive heart failure (New York Heart Association functional classification III-IV)
* Uncontrolled hypertension (mmHg \> 160 systolic or \> 90 diastolic)
* Patients should not have active infections or concurrent neoplastic disease except for skin cancer
* Patients may not be receiving any other investigational agents
* At the time of enrollment, patients may not have received any biological, chemotherapy, or radiation therapy
* Patients who may not have received trastuzumab within the prior 6 months for any other reason
* Patients who are pregnant
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
18 Years
ALL
No
Sponsors
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City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Yanghee Woo, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2013-01721
Identifier Type: REGISTRY
Identifier Source: secondary_id
13229
Identifier Type: OTHER
Identifier Source: secondary_id
13229
Identifier Type: -
Identifier Source: org_study_id
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