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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Chemotherapy; Neoadjuvant Therapy; Hormone Replacement 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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

20 patients who present to the Internal Medicine Breast Cancer Clinic with breast cancer and who after discussion with the consulting surgeon and oncologist have agreed to undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Neoadjuvant therapy for breast cancer; Women who present to the Internal Medicine Breast Cancer Clinic with breast cancer and who after discussion with the consulting surgeon and oncologist have agreed to undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy.

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic News
• Mayo Clinic You Tude Channel

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: November 30, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Estimate): May 10, 2013
• Last Update Submitted That Met QC Criteria: May 8, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: breast cancer; chemotherapy; hormone therapy; neoadjuvant therapy; MBI; Molecular Breast Imaging
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 09-005183