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Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts

This study has been completed.
Sponsor:
Collaborator:
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Deborah Rhodes, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00620373
First received: December 21, 2007
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

We aim to compare the sensitivity of mammography to the sensitivity of Molecular Breast Imaging (a new gamma-camera based breast imaging technology) in women with dense breast tissue who are at increased risk for breast cancer.


Condition Intervention
Breast Cancer
 Device: Molecular Breast Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluation of Low-dose Molecular Breast Imaging as a Screening Tool in Women With Mammographically Dense Breasts and Increased Risk of Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Sensitivity of MBI relative to sensitivity of mammography [ Time Frame: Mammogram and MBI must be done within 30 days at Mayo Clinic Rochester ] [ Designated as safety issue: No ]

Enrollment: 2657
Study Start Date: August 2005
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Molecular Breast Imaging
    Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
Detailed Description:

The sensitivity of conventional mammography (MMO) is poor in women with mammographically dense breast parenchyma. We have developed Molecular Breast Imaging (MBI) - a new technique which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography that has a high sensitivity (~90%) for the detection of breast cancers independent of breast density.

The aim of this study is to demonstrate the utility of MBI as an adjunct screening modality for the detection of occult breast cancers in women with mammographically dense breast tissue. The study will comprise 3500 women. Initial recruitment will be from the pool of patients awaiting a screening mammogram in the Department of Radiology at Mayo Clinic Rochester. All patients will have a screening MMO and an MBI study. Patients with positive studies (MBI or MMO) will undergo additional diagnostic studies. At 15 months post-recruitment, all patients will be contacted by phone or mail to determine whether subsequent to their study, there has been any change in their breast status.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Past prior SM interpreted as negative or benign (MUST BE PREFORMED AT MAYO CLINIC ROCHESTER)
  • Past prior SM interpreted as heterogeneously dense or extremely dense (MUST BE PREFORMED AT MAYO CLINIC ROCHESTER)
  • Age 40 or older

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.
  • They have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.).
  • They have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study.
  • They are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00620373

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: Deborah J. Rhodes, M.D. Mayo Clinic
  More Information

Additional Information:
Mayo Clinic News  This link exits the ClinicalTrials.gov site
Mayo Clinic Discovery Edge Online Magazine  This link exits the ClinicalTrials.gov site
Mayo Clinic You Tube Channel  This link exits the ClinicalTrials.gov site

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Deborah Rhodes, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00620373     History of Changes
Other Study ID Numbers: 1337-05, Susan G. Komen Foundation
Study First Received: December 21, 2007
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Dense breast tissue
Breast Cancer Screening
Molecular Breast Imaging
Breast Cancer
Breast

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013