Breast Cancer
Conditions
Keywords
Benign breast disease, Breast, MRI, Mammography, Ultrasound, Molecular Breast Imaging, Breast Cancer
Brief summary
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.
Detailed description
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.
Interventions
DEVICEMolecular 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.
Sponsors
United States Department of Defense
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* This study will include a population of women aged 25 or older who are scheduled for a breast MRI examination at MAYO CLINIC ROCHESTER. * Patients must not be lactating or pregnant. * All women of child-bearing potential must have had a negative urine pregnancy test result within 2 days prior to the MBI study. * women who are scheduled for a breast MRI examination for a clinical concern, problem solving or for further evaluation of invasive breast cancer (e.g. pre-operative staging of known breast cancer).
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. * The breast MRI is for screening purposes or to determine the status of breast augmentation. * They have undergone breast surgery within the previous year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity on the Per Patient Level | within 1 week of surgery or biopsy | Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity on the Per Tumor Level | within 1 week of surgery or biopsy | Number of tumors detected per number of tumors diagnosed on surgery or biopsy. |
| Specificity | at least one year following imaging | The number of women with negative imaging test per number of women without cancer. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Participants There are no arms or subgroups in this study. | 89 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Incomplete Imaging | 5 |
Baseline characteristics
| Characteristic | Study Participants |
|---|---|
| Age, Continuous | 53 Years |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 89 |
| serious Total, serious adverse events | 0 / 89 |
Outcome results
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.
Time frame: within 1 week of surgery or biopsy
Population: In the 84 patients who completed the study 28 were diagnosed with breast cancer.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Sensitivity on the Per Patient Level | Sensitivity by MBI | 25 participants |
| Study Participants | Sensitivity on the Per Patient Level | Sensitivity by MRI | 27 participants |
Secondary
Sensitivity on the Per Tumor Level
Number of tumors detected per number of tumors diagnosed on surgery or biopsy.
Time frame: within 1 week of surgery or biopsy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Sensitivity on the Per Tumor Level | sensitivity by MBI | 32 tumors |
| Study Participants | Sensitivity on the Per Tumor Level | sensitivity by MRI | 36 tumors |
Secondary
Specificity
The number of women with negative imaging test per number of women without cancer.
Time frame: at least one year following imaging
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Participants | Specificity | specificity by MBI | 38 participants |
| Study Participants | Specificity | specificity by MRI | 37 participants |