Copper Cu 64-DOTA-B-Fab PET/CT in Imaging Patients With Ovarian and Breast Cancer
NCT ID: NCT02708511
Last Updated: 2018-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
2 participants
INTERVENTIONAL
2016-08-31
2017-10-11
Brief Summary
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Detailed Description
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I. To determine the dosimetry of 64Cu-DOTA B-Fab (copper Cu 64-DOTA-B-Fab).
SECONDARY OBJECTIVES:
I. To evaluate the safety of 64Cu-DOTA B-Fab single administration.
II. To evaluate the ability of 64Cu-DOTA B-Fab to detect CA6-positive ovarian and breast cancer lesions.
III. To compare PET results with the immunohistochemistry (IHC) analysis of the excised tumor samples.
OUTLINE:
Patients receive copper Cu 64-DOTA-B-Fab intravenously (IV) followed by PET/CT 60 minutes post-injection and 24 hours post-injection
After completion of study, patients are followed up for 12 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (Cu 64 DOTA-B-Fab)
Patients receive copper Cu 64-DOTA-B-Fab IV followed by PET/CT 60 minutes post-injection and 24 hours post-injection
Computed Tomography
Undergo PET/CT
Copper Cu 64-DOTA B-Fab
Given IV
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Positron Emission Tomography
Undergo PET/CT
Interventions
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Computed Tomography
Undergo PET/CT
Copper Cu 64-DOTA B-Fab
Given IV
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Positron Emission Tomography
Undergo PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Patient is ≥ 18 years old at the time of the drug administration
2. Participant has suspected or biopsy proven ovarian cancer and is scheduled to undergo surgical excision of the cancerous lesion(s) OR Participant has biopsy proven ovarian cancer but is not a surgical candidate
3. Ability to understand and the willingness to sign a written informed consent document.
4. Patient is able to remain still for duration of each imaging procedure
Breast Cancer Participants
1. Patient is ≥ 18 years old at the time of the drug administration
2. Participant has biopsy proven breast cancer and may or may not undergo surgical excision of the cancerous lesion(s)
3. Ability to understand and the willingness to sign a written informed consent document.
4. Patient is able to remain still for duration of each imaging procedure
Exclusion Criteria
1. Patient is pregnant or breast-feeding
2. Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures.
3. Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements
4. Patients participating in other research imaging protocols will be excluded from this study.
Breast Cancer Participants
1. Patient is pregnant or breast-feeding
2. Patients with contraindications for PET/CT or who cannot complete a PET/CT scan or other study procedures.
3. Patients with serious uncontrolled concurrent medical illness that would limit compliance with study requirements
4. Patients participating in other research imaging protocols will be excluded from this study.
18 Years
FEMALE
No
Sponsors
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Sanjiv Sam Gambhir
OTHER
Responsible Party
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Sanjiv Sam Gambhir
Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research
Principal Investigators
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Sanjiv Gambhir
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University, School of Medicine
Palo Alto, California, United States
Countries
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Other Identifiers
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NCI-2015-00767
Identifier Type: REGISTRY
Identifier Source: secondary_id
32991
Identifier Type: -
Identifier Source: secondary_id
GYNOVA0033
Identifier Type: OTHER
Identifier Source: secondary_id
IRB-32991
Identifier Type: OTHER
Identifier Source: secondary_id
GYNOVA0033
Identifier Type: -
Identifier Source: org_study_id
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