Study to Evaluate the Diagnostic Value of a Combined Molecular Breast Imaging/ Breast Tomosynthesis Modality
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ClinicalTrials.gov Identifier: NCT01024114 |
Recruitment Status :
Withdrawn
First Posted : December 2, 2009
Last Update Posted : April 18, 2012
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Condition or disease |
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Breast Cancer |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Pilot Study to Evaluate the Incremental Diagnostic Value of a Combined Molecular Breast Imaging / Breast Tomosynthesis Modality |
Study Start Date : | July 2009 |
Estimated Primary Completion Date : | December 2012 |

Group/Cohort |
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Positive MBI scan
Women who are previously enrolled in an MBI study that present with a positive MBI scan.
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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, Learn About Clinical Studies.
Ages Eligible for Study: | 25 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- over the age of 25
- enrolled in one of the following protocols:
IRB # 08-005522: Evaluation of Molecular Breast Imaging in Patients with a High Likelihood of Ductal Carcinoma in Situ. 07-004241: Molecular Breast Imaging in the Preoperative Evaluation of Women with Biopsy Proven Breast Cancer. 1204-03: Evaluation of a Small Field of View Gamma Camera for Scintimammography in Patients with Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia, and Lobular Carcinoma In Situ. 07-003397: Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation. 17-05: Determination of the Sensitivity of a Dual-Headed Small Field of View Gamma Camera for the Detection of Small Breast Lesions.
- Digital mammogram at the Mayo Clinic within the past 30 days
Exclusion Criteria:
- They are unable to understand and sign the consent form
- They are pregnant or lactating
- They are physically unable to sit upright and still for 40 minutes.
- Recently enrolled on one of the ongoing tomosynthesis vs. mammography studies (rationale - avoid performing duplicate tomosynthesis studies in the same patient)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024114
United States, Minnesota | |
Mayo Clinic - Rochester | |
Rochester, Minnesota, United States, 55905 |
Principal Investigator: | Michael K. O'Connor, Ph.D | Mayo Clinic |
Responsible Party: | Amy L. Conners, MD, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT01024114 |
Other Study ID Numbers: |
09-002678 |
First Posted: | December 2, 2009 Key Record Dates |
Last Update Posted: | April 18, 2012 |
Last Verified: | April 2012 |
MBI Molecular Breast Imaging Breast Cancer Positive Molecular Breast Imaging scan. |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |