Screening in Myocardial Perfusion Patients

Breast Cancer Clinical Trial

Official title:

Screening for Breast Cancer in Patients Undergoing Myocardial Perfusion Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943241
• Other study ID #: 08-001046
• Status: Completed
• Phase: N/A
• First received: July 20, 2009
• Last updated: February 12, 2013
• Start date: July 2008
• Est. completion date: June 2010

Study information

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

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Gamma Medica-Ideas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biopsy-proven breast cancer		12 months	No