New Technique as an Additional Diagnostic Tool for Women Undergoing Neoadjuvant Therapy for Breast Cancer

NCT00566085 | Completed

• 1 other identifier: 07-002067
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Molecular Breast Imaging is a highly promising novel methodology for breast cancer detection. Preliminary patient studies with our dual-detector system indicate that this system is capable of reliably detecting very small (5-10 mm) malignant lesions in the breast. Besides the usefulness of Molecular Breast Imaging for tumor detection, we speculate that tumor uptake and washout may be predictors to response to neoadjuvant therapy for patients with the diagnosis of breast cancer. We propose that in patients with breast cancer who undergo neoadjuvant chemotherapy or neoadjuvant hormone therapy that molecular breast imaging is an accurate test for assessing response rate to neoadjuvant therapy.

Conditions

Breast Cancer

Keywords

MBI; Breast Cancer; Neoadjuvant Therapy; Molecular Breast Imaging

Outcome Measures

Primary Outcomes (1)

• To document that pre- and post-neoadjuvant therapy tumor size can be satisfactorily assessed by molecular breast imaging and corresponds to tumor size evaluation by conventional breast imaging procedures (mammogram, ultrasound, MRI).

  Up to 6 months

Secondary Outcomes (2)

• To document that post-neoadjuvant tumor size as determined by molecular breast imaging corresponds to tumor size found at time of surgery.

  Up to 6 months

• To characterize patterns of tumor uptake and washout and determine if they are predictors of response to neoadjuvant chemotherapy or neoadjuvant hormone therapy.

  Up to 6 months

Study Arms (1)

Molecular Breast Imaging

OTHER

Procedure: Molecular Breast Imaging

Interventions

Molecular Breast Imaging PROCEDURE

A dual-detector cadmium-zinc-telluride gamma camera system mounted on a modified mammography gantry is used to image the breast. The injection dose of the radiopharmaceutical given to the patient is 28-32 mCi of 99m Tc-sestamibi.

Also known as: MBI

Molecular Breast Imaging

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women age 18 - 90
• Women with breast cancer scheduled to undergo neoadjuvant chemotherapy therapy or neoadjuvant hormone therapy
• Women who have undergone any breast imaging procedure, and in whom a repeat imaging procedure is planned prior to definite surgery

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• Smith IE, Lipton L. Preoperative/neoadjuvant medical therapy for early breast cancer. Lancet Oncol. 2001 Sep;2(9):561-70. doi: 10.1016/S1470-2045(01)00490-9.

  PMID: 11905711 BACKGROUND

• Chow LW, Yiu CC, Yip AY, Loo WT. The future perspectives of breast cancer therapy. Biomed Pharmacother. 2006 Jul;60(6):259-62. doi: 10.1016/j.biopha.2006.06.010. Epub 2006 Jun 23.

  PMID: 16824726 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dietlind L. Wahner-Roedler, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 30, 2007
• First Posted: December 3, 2007
• Study Start: January 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 6, 2012

Record last verified: 2012-01

Locations

US (1)