Molecular Breast Imaging (MBI) in Patients With Suspected Ductal Carcinoma in Situ (DCIS)
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic
First received: April 29, 2009
Last updated: February 24, 2014
Last verified: February 2014
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.
||Observational Model: Case-Only
Time Perspective: Cross-Sectional
||Evaluation of Molecular Breast Imaging in Patients With a High Likelihood of Ductal Carcinoma in Situ
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
Suspected with breast cancer
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.
|Ages Eligible for Study:
||25 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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.
- Unable to understand or sign a consent form.
- Pregnant or lactating.
- Physically unable to sit upright and still for 30-40 minutes.
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: NCT00890994
|Rochester, Minnesota, United States, 55905 |
||Dietlind L. Wahner-Roedler, MD
No publications provided
||Dietlind Wahner-Roedler, MD, Mayo Clinic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 29, 2009
||February 24, 2014
||United States: Institutional Review Board
Keywords provided by Mayo Clinic:
Molecular Breast Imaging
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary