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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01023802
First received: November 30, 2009
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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.


Condition
Neoadjuvant Therapy
Chemotherapy
Hormone Replacement Therapy
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Enrollment: 20
Study Start Date: February 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01023802

Locations
United States, Minnesota
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Dietlind L. Wahner-Roedler, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Dietlind Wahner-Roedler, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01023802     History of Changes
Other Study ID Numbers: 09-005183
Study First Received: November 30, 2009
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
neoadjuvant therapy
chemotherapy
hormone therapy
breast cancer
MBI
Molecular Breast Imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 19, 2014