Breast Abnormalities
Conditions
Keywords
molecular breast imaging, breast disease, breast biopsy
Brief summary
The primary hypothesis of this project is that using molecular breast imaging (MBI) in evaluating women with equivocal mammographic or sonographic findings will demonstrate high specificity in distinguishing benign from malignant breast disease and, as a result, decrease the number of biopsies.
Interventions
DEVICEmolecular breast imaging (Discovery)
Sponsors
GE Healthcare
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Women who have indeterminate mammographic or sonographic findings who are recommended and for biopsy
Exclusion criteria
* Known contraindication to mammographic imaging * women who are pregnant * women who are lactating * women who have significant existing breast trauma * women who have breast implants * Women under 18 years of age. * women who had previous benign breast surgery within 1 year * Males and children * Women who are unable to understand or execute written informed consent * Women who refuse to have a biopsy * Women with any known renal disease - if an MRI is deemed necessary, a serum creatine will be checked prior to injection of contrast. Using the National Kidney Foundation recommendations, a glomerular filtration rate (GFR) greater than 60 may safely receive intravenous gadolinium-based MRI contrast. Those individuals with a GFR \>30 and \<60 can receive the contrast but at a reduced dose (typically half). Those with a GFR \<30 will not receive MRI contrast and will not undergo the exam. Breast MRI must be done with contrast if evaluating for cancer. Several factors can affect the GFR such as age, body size, creatinine, renal status and will be calculated from the blood drawn. GFR is the final determinant and a creatinine greater than 1.6 usually has a GFR that precludes a Breast MRI with contrast. The final determinant will be the GFR.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results. | 1 year | The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results. | 1 year | Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives). |
Countries
United States
Participant flow
Recruitment details
single group
Participants by arm
| Arm | Count |
|---|---|
| Molecular Breast Imaging molecular breast imaging (Discovery) | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Molecular Breast Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants |
| Age, Continuous | 56 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 60 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 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.
The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).
Time frame: 1 year
Population: Analysis population included the number of indeterminate lesions that had negative/benign pathology results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Molecular Breast Imaging | Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results. | 27 lesions |
Secondary
Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.
Reported are the number of indeterminate lesions with marked, moderate, or mild uptake and positive pathology results (true positives).
Time frame: 1 year
Population: Analysis population included the number of indeterminate lesions that had positive pathology results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Molecular Breast Imaging | Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results. | 19 lesions |