Expired Study
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Rochester, Minnesota 55905


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

07-004241


NCT ID:

NCT00776308


Secondary ID:

NIH Grant: CA128407-01


Study Acronym:

MBI


Brief Title:

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


Official Title:

Molecular Breast Imaging in the Preoperative Evaluation of Women With Biopsy Proven Breast Cancer


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

25 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Mayo Clinic


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

98


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael K O'Connor, Ph.D.
Study Director
Mayo Clinic

Study Dates

Start Date:October 2008
Completion Date:February 2011
Completion Type:Actual
Primary Completion Date:February 2011
Primary Completion Type:Actual
Verification Date:January 2012
Last Changed Date:January 23, 2012
First Received Date:October 20, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Mayo Clinic
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Gamma Medica-Ideas

Samples and Retentions

Study Population: Recruitment will be from the pool of patients undergoing surgical evaluation for breast cancer at Mayo Clinic Rochester.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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