Molecular Breast Imaging (MBI) in Patients With Suspected Ductal Carcinoma in Situ (DCIS)
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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: | Observational Model: Case-Only Time Perspective: 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 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Suspected with breast cancer |
Detailed Description:
Patients who are suspected to have DCIS based on mammographic findings will be invited to participate in this study. The investigators 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:
- Women with a breast lesion suspicious for DCIS who are scheduled for a stereotactic breast biopsy.
- Lesion must be considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4 or 5).
- Women between 25 and 90 years of age.
Exclusion Criteria:
- Unable to understand or sign a consent form.
- Pregnant or lactating.
- Physically unable to sit upright and still for 30-40 minutes.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Dietlind Wahner-Roedler, MD, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00890994 History of Changes |
| Other Study ID Numbers: | 08-005522 |
| Study First Received: | April 29, 2009 |
| Last Updated: | February 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
MBI Molecular Breast Imaging Breast Cancer DCIS |
Breast Calcifications Microcalcifications |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Carcinoma, Ductal Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary |
ClinicalTrials.gov processed this record on June 18, 2013