Screening in Myocardial Perfusion Patients

Screening for Breast Cancer in Patients Undergoing Myocardial Perfusion Imaging

To expand the understanding of the uptake and distribution of Tc-99m sestamibi in the breast in a normal female population undergoing myocardial perfusion imaging using Molecular Breast Imaging (MBI).

Study Overview

• Status: Completed
• Conditions: Breast Cancer

Detailed Description

You are being asked to take part in this research study because you have been scheduled to have a scan of your heart. The radioactive dye used to image your heart is also taken up by many types of breast cancer. The investigators have developed a new method for detecting breast cancer, called Molecular Breast Imaging that uses this dye.

The purpose of this study is to see how well this new method works in normal subjects with no known breast cancer and to see if we can detect breast cancer at an earlier stage than mammography. As you read this form describing the study, ask any questions you have. Take your time to decide. Feel free to discuss the study with your family, friends, and healthcare provider before you decide. You may stop participating at any time during the study. You may decide not to participate. If so, none of your current benefits or normal health care will be affected in any way. When you feel comfortable that all your questions have been answered, and you wish to take part in this study, sign this form in order to begin your participation. Your signature means you have been told about the study and what the risks are. Your signature on this form also means that you want to take part in this study.

• Study Type: Observational
• Enrollment (Actual): 322

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female subjects who are undergoing Myocardial Perfusion imaging in the Nuclear Cardiology laboratory at the Mayo Clinic in Rochester, MN.

Description

Inclusion Criteria:

• They have had a mammogram at Mayo Clinic Rochester within the last 12 months
• Undergoing myocardial perfusion imaging

Exclusion Criteria:

• They are unable to understand and sign the consent form
• They are physically unable to sit upright and still for 20 minutes
• They have undergone breast surgery or breast biopsy within the last 12 months.
• They have had trauma to the breast tissue or undergone radiation treatment to the breast within the last 12 months.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Biopsy-proven breast cancer	12 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Gamma Medica-Ideas
• Investigators: Principal Investigator: Deborah J. Rhodes, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: July 20, 2009
• First Submitted That Met QC Criteria: July 20, 2009
• First Posted (Estimate): July 22, 2009

Study Record Updates

• Last Update Posted (Estimate): February 13, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Breast Cancer; MBI; Breast; Molecular Imaging; Molecular Breast Imaging
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 08-001046