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

April 16, 2012 updated by: Amy L. Conners, Mayo Clinic

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 Overview

Status

Withdrawn

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Positive MBI scan
Women who are previously enrolled in an MBI study that present with a positive MBI scan.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Michael K. O'Connor, Ph.D, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

April 18, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-002678

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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