Use of Molecular Breast Imaging (MBI) to Detect Additional Disease in Women With Breast Cancer Who Are About to go to Surgery

NCT00776308 | Completed

• 2 other identifiers: 07-004241NIH Grant: CA128407-01
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Conventional mammography is not a reliable method for determining the extent of disease in women with breast cancer. Molecular Breast Imaging (MBI) is a new nuclear medicine technique that allows the breast to be imaged in a manner similar to mammography, but without the pain of compression. Initial results with this method have shown it is very good at detecting small breast cancers (\~1/4 inch). The purpose of this study is to see if MBI is a better method than mammography in determining how much cancer is present before a woman goes to surgery. The study will comprise 120 women with breast cancer who are going to surgery. The investigators hope that this study will demonstrate that MBI will be more accurate in determining how much cancer is present.

Conditions

Breast Cancer

Keywords

molecular breast imaging; breast cancer; mammography

Outcome Measures

Primary Outcomes (1)

• The gold standard for assessing MBI will be tissue pathology. Using pathology as the gold standard, we will compare the sensitivity of MBI to that of mammography in the evaluation of this patient population.

  At surgery

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment will be from the pool of patients undergoing surgical evaluation for breast cancer at Mayo Clinic Rochester.

You may qualify if:

• Women with biopsy-proven breast cancer (invasive breast cancer or ductal carcinoma in situ)

You may not qualify if:

• Unable to understand and sign the consent form
• Pregnant or lactating
• Physically unable to sit upright and still for 40 minutes
• Currently receiving neoadjuvant chemotherapy or hormonal therapy
• Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor
• Previous mastectomy
• Previous excisional biopsy of the index breast cancer

Sponsors & Collaborators

• Mayo Clinic: lead
• Gamma Medica-Ideas: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic News
• Mayo Clinic You Tube Channel

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael K O'Connor, Ph.D.

  Mayo Clinic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 21, 2008
• Study Start: October 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: January 25, 2012

Record last verified: 2012-01

Locations

US (1)