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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
  Purpose

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).


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Screening for Breast Cancer in Patients Undergoing Myocardial Perfusion Imaging

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Biopsy-proven breast cancer [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 322
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943241

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Gamma Medica-Ideas
Investigators
Principal Investigator: Deborah J. Rhodes, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Deborah Rhodes, Assistant Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00943241     History of Changes
Other Study ID Numbers: 08-001046
Study First Received: July 20, 2009
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Breast
Breast Cancer
MBI
Molecular Breast Imaging
Molecular Imaging

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014