Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer
NCT ID: NCT02810873
Last Updated: 2025-05-04
Study Results
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View full resultsBasic Information
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TERMINATED
NA
19 participants
INTERVENTIONAL
2008-09-30
2012-07-31
Brief Summary
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Detailed Description
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I. The study's primary goal is to assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect primary breast lesions as determined by the F-18-FDG (fludeoxyglucose F 18) scan.
II. The study's second goal is to determine the ability of Cu-64-TP3805 to detect primary breast lesions as determined by histology (sensitivity).
III. The study's third goal is to determine the ability of Cu-64-TP3805 to detect metastatic lesions as identified by the F-18-FDG whole-body scan.
OUTLINE: This is a dose-finding 2-stage study.
STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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F-18-FDG Whole body Scan
STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
Positron Emission Mammography
Undergo PEM Positron Emission Mammography scan
Fludeoxyglucose F-18
Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Copper Cu 64 TP3805
Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
No F-18-FDG Scan
STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.
Positron Emission Tomography
Undergo PET Positron Emission Tomography scan
Fludeoxyglucose F-18
Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Copper Cu 64 TP3805
Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Interventions
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Positron Emission Mammography
Undergo PEM Positron Emission Mammography scan
Positron Emission Tomography
Undergo PET Positron Emission Tomography scan
Fludeoxyglucose F-18
Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Copper Cu 64 TP3805
Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Breast cancer shown with abnormal mammogram and histology verification (stage-1 patients will also need to have a positive F-18-FDG whole-body scan)
* Tumor mass of 1 cm or larger, as determined by mammography, ultrasound, or magnetic resonance imaging (MRI)
* Signed informed consent form approved by the institutional review board (IRB)
Exclusion Criteria
* Patient with asthma
18 Years
FEMALE
No
Sponsors
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National Institutes of Health (NIH)
NIH
Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER
Responsible Party
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Principal Investigators
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Madhukar Thakur, PhD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Related Links
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Thomas Jefferson University Hospital
Other Identifiers
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JT 1419
Identifier Type: OTHER
Identifier Source: secondary_id
08F.327
Identifier Type: -
Identifier Source: org_study_id
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