Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2010-04-08
2011-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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All Participants
18F-FLT-PET imaging
18F-FLT-PET/CT Imaging
Participants receive the investigational radiotracer 18F-FLT intravenously and undergo Positron Emission Tomography (PET)/Computed Tomography (CT) scans at the following three times: prior to initiation of chemotherapy, at the end of the first cycle of treatment, and at the conclusion of chemotherapy.
Interventions
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18F-FLT-PET/CT Imaging
Participants receive the investigational radiotracer 18F-FLT intravenously and undergo Positron Emission Tomography (PET)/Computed Tomography (CT) scans at the following three times: prior to initiation of chemotherapy, at the end of the first cycle of treatment, and at the conclusion of chemotherapy.
Eligibility Criteria
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Inclusion Criteria
* Is eligible for pre-operative (neo-adjuvant) chemotherapy
Exclusion Criteria
* Any condition that would limit ability to undergo MRI or PET scans
* Is a nursing mother
* Has moderate to end-stage renal disease and is not on dialysis or has renal failure on chronic dialysis
35 Years
75 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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2009_692
Identifier Type: OTHER
Identifier Source: secondary_id
0000-139
Identifier Type: -
Identifier Source: org_study_id
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