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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023802
• Other study ID #: 09-005183
• Status: Completed
• Phase: N/A
• First received: November 30, 2009
• Last updated: May 8, 2013
• Start date: February 2009
• Est. completion date: February 2011

Study information

• Verified date: May 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chemotherapy
• Hormone Replacement Therapy
• Neoadjuvant Therapy

Locations

Country	Name	City	State
United States	Mayo Clinic - Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

External Links

•   Mayo Clinic News
•   Mayo Clinic You Tude Channel