Breast Neoplasms Clinical Trial
Official title:
Pilot Study: Dedicated Dual Head Molecular Breast Imaging Compared to Breast Tomosynthesis for Evaluation of Patients With Type 3 or 4 Mammographic Breast Density
Verified date | August 2014 |
Source | Gamma Medica, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Primary:
In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI
(Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in
detecting breast cancer than breast tomosynthesis.
Secondary:
1. In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly
classifying subjects without breast cancer will be non-inferior to breast
tomosynthesis.
2. In women with heterogeneous or dense breast tissue, the area under the receiver
operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast
tomosynthesis.
3. Combining the use of MBI and breast tomosynthesis will provide performance superior to
either technology alone, as manifest by a superior ROC curve area.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2017 |
Est. primary completion date | October 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years and older |
Eligibility |
Inclusion Criteria: - Women over 25 years of age with normal or increased risk of breast cancer. - Women with type 3 or 4 breast density as determined by a breast imaging radiologist on a current unilateral (women with prior mastectomy) or bilateral mammography (within prior 6 weeks). - No contraindications to breast MBI or breast tomosynthesis. Exclusion Criteria: - Women under the age of 25. - Women who are or may be pregnant. - Women who are currently lactating or have discontinued breast feeding < 2 months prior to the study. - Male patients are excluded as subjects. - Those unable or unwilling to provide informed consent. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Gamma Medica, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity/Cancer detection | Sensitivity being the number of scans read or labeled positive (by radiologist) divided by the total cancers confirmed by pathology results (i.e. biopsy). | 12 months | No |
Secondary | Specificity | Specificity being the total number of scans read or labeled as negative (by a radiologist) divided by number of total women without cancer. This "ground truth" of a true negative will involve in a second negative imaging scan at 12 months (follow-up exam). | 12 months | No |
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