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Clinical Trials/NCT01023802
NCT01023802
Completed
Not Applicable

The Use of Molecular Breast Imaging in the Evaluation of Tumor Response to Neoadjuvant Therapy in Women With Breast Cancer - A Pilot Study

Mayo Clinic1 site in 1 country20 target enrollmentFebruary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neoadjuvant Therapy
Sponsor
Mayo Clinic
Enrollment
20
Locations
1
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

In patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy molecular breast imaging (MBI) is an accurate test for assessing response rate to neoadjuvant therapy.

Detailed Description

The investigators propose to evaluate Molecular Breast Imaging in patients undergoing neoadjuvant therapy for breast cancer with the aims to document that 1) the change in uptake of 99mTc-sestamibi prior to initiation of neoadjuvant therapy, after 3-5 weeks of neoadjuvant therapy and at completion of neoadjuvant therapy prior to breast cancer surgery will be a reflection of the tumor response to neoadjuvant therapy. 2) Tumor response at 3-5 weeks of neoadjuvant therapy is predictive of tumor response at completions of neoadjuvant therapy. 3) Post-neoadjuvant tumor size as determined by MBI corresponds to size found at surgery.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
February 2011
Last Updated
12 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dietlind Wahner-Roedler

M.D.

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

  • Women with breast cancer scheduled to undergo neoadjuvant chemotherapy therapy or neoadjuvant hormone therapy and who have undergone any breast imaging procedure, and in whom a repeat imaging procedure is planned prior to definite surgery. MRI of the breast for accurate tumor size evaluation is recommended but not necessarily required for study inclusion.
  • Are able to return for a 3-5 week follow-up MBI study and for the final MBI study at completion of the neoadjuvant therapy.
  • Patient age \> 18

Exclusion Criteria

  • Unable to understand or sign a consent form
  • Pregnant or lactating
  • Physically unable to sit upright and still for 40 minutes

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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