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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of this study is to determine the sensitivity of Molecular Breast Imaging (MBI) relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal diagnostic mammogram and/or ultrasound study.
Background: Breast MRI has excellent sensitivity, but is very expensive and suffers from low specificity. Additional benign biopsies are prompted by MRI in 24-40% of patients. Molecular Breast Imaging (MBI) is a new nuclear medicine technique developed at Mayo. Preliminary MBI results indicate a sensitivity of ~88% for the detection of tumors < 10 mm. The cost of an MBI procedure is expected to be a factor of 5 less than an MRI examination.
Hypothesis: MBI has a comparable sensitivity to MRI at a significantly lower cost.
Study Design: A total of 120 patients will be studied. All patients will have been scheduled for bilateral breast MRI at Mayo Clinic Rochester for a clinical concern, problem solving, or abnormal mammogram and/or ultrasound study. All patients will undergo MBI within 3 weeks of the MRI examination.
Potential Outcomes: This study will provide valuable information on the sensitivity of MBI relative to MRI, and to determine if this new technique can be eventually developed as an alternative to MRI for problem solving.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molecular Breast Imaging | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity on the Per Patient Level | Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy. | within 1 week of surgery or biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity on the Per Tumor Level | Number of tumors detected per number of tumors diagnosed on surgery or biopsy. | within 1 week of surgery or biopsy |
| Specificity | The number of women with negative imaging test per number of women without cancer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic You Tube Channel | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Imaged With MBI and MRI | The group includes patients who underwent both MBI and breast MRI within the same 3 week period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | There are no arms or subgroups in this study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity on the Per Patient Level | Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy. | In the 84 patients who completed the study 28 were diagnosed with breast cancer. | Posted | Number | participants | within 1 week of surgery or biopsy |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Participants | There are no arms or subgroups in this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Lynn Conners MD | Mayo Clinic | (507) 284-2511 | MBI@mayo.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| at least one year following imaging |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Sensitivity on the Per Tumor Level | Number of tumors detected per number of tumors diagnosed on surgery or biopsy. | Posted | Number | tumors | within 1 week of surgery or biopsy | tumors | Participants |
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| Secondary | Specificity | The number of women with negative imaging test per number of women without cancer. | Posted | Number | participants | at least one year following imaging |
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| 0 |
| 89 |
| 0 |
| 89 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |