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18F-FLT-PET in Breast Cancer (MK-0000-139)

ClinicalTrials.gov Identifier: NCT01015131 (view full study on clinicaltrials.gov)
Condition:  Breast Cancer
Status:  Completed


Official Title: A Pilot Study to Evaluate the Correlation Between 18F-FLT-PET Uptake, Ki-67 Immunohistochemistry, and Proliferation Signature in Response to Neo-Adjuvant Chemotherapy in Breast Cancer

This study correlated changes from baseline in Ki-67, an immunohistochemical marker of cell proliferation, with changes from baseline in tumor uptake of 3'-deoxy-3'[18F]-fluorothymidine (18F-FLT) following the first cycle of treatment with standard of care neo-adjuvant therapy in participants with breast cancer.

Study Type:
Interventional
Study Phase:
Phase 2
Enrollment:
46
Study Start Date:
April 2010
Study Completion Date:
December 2011
Primary Completion Date:
May 2011
Ages Eligible for Study:
35 years to 75 years
Genders Eligible for Study:
Female
Accepts Healthy Volunteers:
No


CRITERIA

Inclusion Criteria:

  • Has newly-diagnosed stage IIB/IIIA/IIIB locally advanced breast cancer
  • Is eligible for pre-operative (neo-adjuvant) chemotherapy

Exclusion Criteria:

  • Has a contraindication to magnetic resonance imaging (MRI)
  • 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

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