Study to Evaluate the Diagnostic Value of a Combined Molecular Breast Imaging/ Breast Tomosynthesis Modality
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...
Brief Summary
Official Title: “Pilot Study to Evaluate the Incremental Diagnostic Value of a Combined Molecular Breast Imaging / Breast Tomosynthesis Modality”
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.
- Study Type: Observational
- Study Design: Observational Model: Case-Only, Time Perspective: Prospective
- Study Primary Completion Date: December 2012
Detailed Clinical Trial 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.
Arms, Groups and Cohorts in this Clinical Trial
- : Positive MBI scan
- Women who are previously enrolled in an MBI study that present with a positive MBI scan.
Criteria for Participation in this Clinical Trial
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)
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 25 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Mayo Clinic Other
Overall Clinical Trial Officials and Contacts
Michael K. O'Connor, Ph.D Principal Investigator Mayo Clinic
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01024114
Study ID Number: 09-002678
ClinicalTrials.gov Identifier: NCT01024114
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01024114
