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: July 30, 2014
Last verified: July 2014
  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
Device: Conventional Mammography
Drug: Technetium (99mTc) sestamibi

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:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Diagnostic Yield [ Time Frame: 12 months after mammography and gamma imaging ] [ Designated as safety issue: No ]
    Diagnostic yield is the likelihood that a test or procedure will provide the information needed to establish a diagnosis. In this case, it is the proportion of women with positive results of a screening test and positive results with the reference standard (verified cancer status).

  • Number of Participants With Cancer Diagnosis at 12 Months [ Time Frame: 12 months after mammography and gamma imaging ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity [ Time Frame: 12 months after mammography and gamma imaging ] [ Designated as safety issue: No ]
    Sensitivity measures the proportion of actual positives which are correctly identified as such.

  • Specificity [ Time Frame: 12 month after mammography and gamma imaging ] [ Designated as safety issue: No ]
    Specificity measures the proportion of negatives which are correctly identified as such.

  • Recall Rate [ Time Frame: 12 months after mammography and gamma imaging ] [ Designated as safety issue: No ]
    Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or gamma imaging.


Enrollment: 969
Study Start Date: August 2005
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mammography and Molecular Breast Imaging
Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (20-mCi) Technetium (99mTc) sestamibi injection.
Device: Molecular Breast Imaging
Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
Device: Conventional Mammography
Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.
Drug: Technetium (99mTc) sestamibi
Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands.
Other Name: Cardiolite

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. 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:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Past prior screening mammography (SM) interpreted as negative or benign (This screening must have been performed at Mayo Clinic Rochester, Minnesota).
  2. Past prior SM interpreted as heterogeneously dense or extremely dense (This screening must have been performed at Mayo Clinic Rochester, Minnesota).
  3. Women younger than 50 years who had not undergone prior mammography, as most of these women have dense breasts.
  4. Subjects had to have at least one of the following risk factors:

    1. Known mutation in breast cancer susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2)
    2. History of chest, mediastinal, or axillary irradiation
    3. Personal history of breast cancer
    4. History of prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or atypical papilloma
    5. Gail or Claus model lifetime risk greater than or equal to 20%
    6. Gail model 5 year risk greater or equal to 2.5%
    7. Gail model 5 year risk greater or equal to 1.6%
    8. One first-degree relative with history of breast cancer
    9. Two second-degree relatives with history of breast cancer

Exclusion Criteria:

  1. They are unable to understand and sign the consent form
  2. They are pregnant or lactating
  3. They are physically unable to sit upright and still for 40 minutes.
  4. They have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.).
  5. They have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study.
  6. They are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
Responsible Party: Deborah Rhodes, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00620373     History of Changes
Other Study ID Numbers: 1337-05 Part A, Susan G. Komen Foundation
Study First Received: December 21, 2007
Results First Received: August 15, 2013
Last Updated: July 30, 2014
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
Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014