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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dietlind Wahner-Roedler, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00890994
First received: April 29, 2009
Last updated: July 28, 2014
Last verified: July 2014

April 29, 2009
July 28, 2014
December 2008
December 2015   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00890994 on ClinicalTrials.gov Archive Site
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Molecular Breast Imaging (MBI) in Patients With Suspected Ductal Carcinoma in Situ (DCIS)
Evaluation of Molecular Breast Imaging in Patients With a High Likelihood of Ductal Carcinoma in Situ

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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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.

Breast Cancer
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Suspected with breast cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Female
25 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00890994
08-005522
No
Dietlind Wahner-Roedler, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Dietlind L. Wahner-Roedler, MD Mayo Clinic
Mayo Clinic
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP