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Molecular Breast Imaging (MBI) in Patients With Suspected Ductal Carcinoma in Situ (DCIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00890994
First received: April 29, 2009
Last updated: March 21, 2017
Last verified: March 2017
  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

Resource links provided by NLM:


Further study details as provided by Dietlind Wahner-Roedler, Mayo Clinic:

Enrollment: 200
Actual Study Start Date: January 19, 2009
Study Completion Date: November 14, 2016
Primary Completion Date: November 14, 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Suspected 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   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
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

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Dietlind L. Wahner-Roedler, MD Mayo Clinic
  More Information

Additional Information:
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: March 21, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dietlind Wahner-Roedler, Mayo Clinic:
MBI
Molecular Breast Imaging
Breast Cancer
DCIS
Breast
Calcifications
Microcalcifications

Additional relevant MeSH terms:
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on June 27, 2017