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


N/A
18 Years
N/A
Not Enrolling
Female
Neoadjuvant Therapy, Chemotherapy, Hormone Replacement Therapy, Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Dietlind L. Wahner-Roedler, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

09-005183

NCT ID:

NCT01023802

Start Date:

February 2009

Completion Date:

February 2011

Related Keywords:

  • Neoadjuvant Therapy
  • Chemotherapy
  • Hormone Replacement Therapy
  • Breast Cancer
  • neoadjuvant therapy
  • chemotherapy
  • hormone therapy
  • breast cancer
  • MBI
  • Molecular Breast Imaging
  • Breast Neoplasms

Name

Location

Mayo Clinic - RochesterRochester, Minnesota  55905