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Screening in Myocardial Perfusion Patients

This study has been completed.
Sponsor:
Collaborator:
Gamma Medica-Ideas
Information provided by (Responsible Party):
Deborah Rhodes, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00943241
First received: July 20, 2009
Last updated: February 12, 2013
Last verified: February 2013
History of Changes

July 20, 2009
February 12, 2013
July 2008
June 2010   (final data collection date for primary outcome measure)
Biopsy-proven breast cancer [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00943241 on ClinicalTrials.gov Archive Site
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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).

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Female subjects who are undergoing Myocardial Perfusion imaging in the Nuclear Cardiology laboratory at the Mayo Clinic in Rochester, MN.
Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
322
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00943241
08-001046
No
Deborah Rhodes, Mayo Clinic
Mayo Clinic
Gamma Medica-Ideas
Principal Investigator: Deborah J. Rhodes, M.D. Mayo Clinic
Mayo Clinic
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP