Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-85
SponsorUniversity of Hawaii

About this trial

The objective is to better identify suspicious breast lesions that need to be biopsied for malignancy in women currently recommended for biopsy. The long-term goal is to reduce unnecessary biopsies and increase biopsy yield. To do this, the investigators have developed an innovative way to use FDA-approved breast imaging protocols to acquire multispectral images to measure the composition of suspicious breast lesions. The central hypothesis is that breast tissue composition in combination with analysis of morphological and textural tissue characteristics on digital breast tomosynthesis (DBT) imaging will yield significantly higher breast cancer specificity than conventional interpretation of DBT alone.

Eligibility criteria

Qualifiers

Had a recent diagnostic mammogram with a BI-RADS diagnostic score 4 or 5 assigned by a radiologist (BIRADS are standardized mammography assessment categories: 4 is for "Suspicious abnormality", 5 is for "Highly suggestive of malignancy".

Have not had biopsy

Disqualifiers

Pregnant or breast feeding

History of breast cancer or a mastectomy (removal of the breast) with Systemic Therapy (ex. Chemotherapy, hormones and hormone inhibitors, etc.).

Trial design

Treatments tested in this trial

  • q3CB

Treatment groups

No treatment groups listed

Sponsors and collaborators

University of Hawaii

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Queen's Medical Center

Collaborator

Hawaii Radiologic Associates, Ltd.

Collaborator