Study to Evaluate the Diagnostic Value of a Combined Molecular Breast Imaging/ Breast Tomosynthesis Modality
This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Amy L. Conners, Mayo Clinic
First received: November 30, 2009
Last updated: April 16, 2012
Last verified: April 2012
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||Pilot Study to Evaluate the Incremental Diagnostic Value of a Combined Molecular Breast Imaging / Breast Tomosynthesis Modality
| Study Start Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
Positive MBI scan
Women who are previously enrolled in an MBI study that present with a positive MBI scan.
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.
|Ages Eligible for Study:
||25 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
- 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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024114
|Mayo Clinic - Rochester
|Rochester, Minnesota, United States, 55905 |
||Michael K. O'Connor, Ph.D
No publications provided
||Amy L. Conners, MD, Mayo Clinic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 30, 2009
||April 16, 2012
||United States: Institutional Review Board
Keywords provided by Mayo Clinic:
Molecular Breast Imaging
Positive Molecular Breast Imaging scan.
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 22, 2013
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