Study to Evaluate the Diagnostic Value of a Combined Molecular Breast Imaging/ Breast Tomosynthesis Modality
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Purpose
The purpose of this pilot study is to investigate the potential clinical benefits of combining two new diagnostic tools to provide co-registered anatomical and functional information in the breast in patients with suspected breast cancer.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | 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 |
| Enrollment: | 0 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Positive MBI scan
Women who are previously enrolled in an MBI study that present with a positive MBI scan.
|
Detailed Description:
The purpose of this pilot study is to obtain preliminary data on a new way of imaging the breast that combines the benefits of a 3-D anatomical technique (Digital Tomosynthesis) with those of a functional imaging technique (Molecular Breast Imaging). Combining data from these 2 modalities would provide co-registered functional and anatomical information on the breast, in the same way that PET/CT does today in oncology. This should greatly facilitate the evaluation and biopsy of lesions seen on MBI but occult on conventional mammography.
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All patients will have had a molecular breast imaging study as part of their participation in one of the current research protocols evaluating this technology. A requirement for inclusion in this study is that patients will have had a digital mammography examination at Mayo Clinic within the past 30 days.
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)
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01024114
| United States, Minnesota | |
| Mayo Clinic - Rochester | |
| Rochester, Minnesota, United States, 55905 | |
| Principal Investigator: | Michael K. O'Connor, Ph.D | Mayo Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amy L. Conners, MD, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01024114 History of Changes |
| Other Study ID Numbers: | 09-002678 |
| Study First Received: | November 30, 2009 |
| Last Updated: | April 16, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
MBI Molecular Breast Imaging Breast Cancer Positive Molecular Breast Imaging scan. |
ClinicalTrials.gov processed this record on February 27, 2015