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| Sponsor: | Mayo Clinic |
|---|---|
| Information provided by: | Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00890994 |
Purpose
In this research study, the investigators are testing a new type of breast camera, called Molecular Breast Imaging, to see if it can find tumors in the subject's breast.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Case-Only, Cross-Sectional |
| Official Title: | Evaluation of Molecular Breast Imaging in Patients With a High Likelihood of Ductal Carcinoma in Situ |
| Estimated Enrollment: | 200 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Suspected with breast cancer |
Patients who are suspected to have DCIS based on mammographic findings will be invited to participate in this study. We plan to recruit 200 patients who are scheduled to undergo a breast biopsy for a breast lesion considered suggestive or highly suggestive of DCIS as determined by a radiologist specializing in breast imaging. Each patient will have a suspicious area of calcification on mammography of extent < 3 cm, or a non-focal area of abnormality on ultrasound or MRI that is scheduled for evaluation by biopsy. Each patient will undergo an MBI study immediately prior to biopsy. The study coordinator will approach these patients and inform them of the research project. If they are interested in participating, informed consent will be obtained and the patient will be scheduled for the MBI study prior to the breast biopsy.
Eligibility| Ages Eligible for Study: | 25 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Prospective patients will be identified by the radiologist based on findings in their mammographic, ultrasound or MRI studies. Patients who are suspected to have DCIS based on mammographic findings will be invited to participate in this study.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Beth B Connelly | 507-266-2997 | mbi@mayo.edu |
| Contact: Tammy Hudson | 507-284-4269 | mbi@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Micheal K O'Connor, PhD 507-284-4399 mbi@mayo.edu | |
| Principal Investigator: Dietlind Wahner-Roedler, MD | |
More Information
| Responsible Party: | Mayo Clinic Rochester ( Dr. Dietlind Wahner-Roedler, MD ) |
| Study ID Numbers: | 08-005522 |
| Study First Received: | April 29, 2009 |
| Last Updated: | December 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00890994 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
MBI Molecular Breast Imaging Breast Cancer DCIS |
Breast Calcifications Microcalcifications |
|
Neoplasms by Histologic Type Skin Diseases Breast Neoplasms Carcinoma Carcinoma, Ductal Neoplasms Neoplasms by Site |
Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Breast Diseases Neoplasms, Glandular and Epithelial |
