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Use of Molecular Breast Imaging (MBI) to Detect Additional Disease in Women With Breast Cancer Who Are About to go to Surgery (MBI)

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ClinicalTrials.gov Identifier: NCT00776308
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : January 25, 2012
Sponsor:
Collaborator:
Gamma Medica-Ideas
Information provided by:
Mayo Clinic

Study Description
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Brief Summary:

Conventional mammography is not a reliable method for determining the extent of disease in women with breast cancer. Molecular Breast Imaging (MBI) is a new nuclear medicine technique that allows the breast to be imaged in a manner similar to mammography, but without the pain of compression. Initial results with this method have shown it is very good at detecting small breast cancers (~1/4 inch).

The purpose of this study is to see if MBI is a better method than mammography in determining how much cancer is present before a woman goes to surgery.

The study will comprise 120 women with breast cancer who are going to surgery. The investigators hope that this study will demonstrate that MBI will be more accurate in determining how much cancer is present.


Condition or disease
Breast Cancer

Detailed Description:

The sensitivity of conventional mammography for evaluation of extent of disease, detection of multifocal breast cancers and contralateral breast cancers is poor. Molecular Breast Imaging (MBI) is a new nuclear medicine technique that permits the breast to be imaged in a manner similar to mammography, utilizing a Cadmium-Zinc-Telluride (CZT) gamma camera. We have developed the first dual-head MBI system in the world and preliminary results from this system indicate a high sensitivity (~90%) for the detection of breast cancers < 10mm.

The AIM of this study is to determine the sensitivity of MBI relative to mammography in the preoperative evaluation of the extent of disease in the ipsilateral and contralateral breasts in women with biopsy-proven breast cancer. We will test the HYPOTHESIS that MBI is more sensitive than mammography for preoperative evaluation and surgical planning.

The study will comprise 120 women with biopsy-proven breast cancer prior to surgery. All patients will have a diagnostic mammogram and an MBI study prior to operation. At the time of operation the pathologic findings will be correlated with both the mammogram and the MBI results.

This study will demonstrate the use of MBI in three aspects of breast cancer diagnosis: 1) detection of multifocal / multicentric disease elsewhere in the ipsilateral breast, 2) detection of contralateral breast cancer, and 3) correlation of index tumor size on MBI with pathologic size. These results may justify a role for MBI in the routine pre-operative evaluation of breast cancer patients.

Study Design
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Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular Breast Imaging in the Preoperative Evaluation of Women With Biopsy Proven Breast Cancer
Study Start Date : October 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The gold standard for assessing MBI will be tissue pathology. Using pathology as the gold standard, we will compare the sensitivity of MBI to that of mammography in the evaluation of this patient population. [ Time Frame: At surgery ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Recruitment will be from the pool of patients undergoing surgical evaluation for breast cancer at Mayo Clinic Rochester.
Criteria

Inclusion Criteria:

  • Women with biopsy-proven breast cancer (invasive breast cancer or ductal carcinoma in situ)

Exclusion Criteria:

  • Unable to understand and sign the consent form
  • Pregnant or lactating
  • Physically unable to sit upright and still for 40 minutes
  • Currently receiving neoadjuvant chemotherapy or hormonal therapy
  • Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor
  • Previous mastectomy
  • Previous excisional biopsy of the index breast cancer
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776308


Locations
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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Gamma Medica-Ideas
Investigators
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Study Director: Michael K O'Connor, Ph.D. Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Judy Boughey, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00776308    
Other Study ID Numbers: 07-004241
NIH Grant: CA128407-01
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: January 2012
Keywords provided by Mayo Clinic:
molecular breast imaging
breast cancer
mammography
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases