Study to Evaluate the Diagnostic Value of a Combined Molecular Breast Imaging/ Breast Tomosynthesis Modality

Withdrawn

• Conditions: Breast Cancer

• Registration Number: NCT01024114
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-11-30
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-16
• Last Update Posted: 2012-04-18
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States