Screening in Myocardial Perfusion Patients

NCT ID: NCT00943241

Last Updated: 2013-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

322 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gamma Medica-Ideas

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Deborah Rhodes

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deborah J. Rhodes, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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08-001046

Identifier Type: -

Identifier Source: org_study_id

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