Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 population

All 600 women will be recruited and enrolled from one of three sites: Queen's Medical Center (Honolulu, HI), East Hawaii Women's Imaging Center (Hilo, HI), and H. Lee Moffitt Cancer Center \& Research Institute (Tampa, FL).

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • q3CB

    Diagnostic test

    The q3CB/ncCEM/DBT acquisition protocol consists of a combination of DBT volume reconstructions and projection dual-energy mammograms acquired with a clinical contrast enhanced mammography (CEM) protocol, without contrast administration agent.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Quantify biological composition of lesions

Quantify the biological composition (lipid/water/protein) of suspicious lesions.

Time frame
Baseline
2

Quantify morphology of lesions

Quantify morphology/texture (radiomics) of suspicious lesions.

Time frame
Baseline

Secondary outcomes

1

Comparison of radiologists' image interpretations with and without q3CB signatures

Difference in AUC between the "1st read" and "2nd read" image interpretations. In the "1st read," they will be provided with the FFDM/DBT images and in the "2nd read," they will also be provided with the ncCEM q3CB composition and radiomics signature (likelihood of malignancy).

Time frame
Baseline
2

Sensitivity and Specificity of readers' responses for the BI-RADs assessment categories

Sensitivity and specificity values will be calculated: a BI-RADS assessment of 4a or higher (i.e., 4a, 4b, 4c, and 5) defined a positive call for cancer diagnosis and, conversely, a BI-RADS assessment of 3 or lower (i.e., 3, 2, and 1) defined a negative call for cancer diagnosis.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Hawaii

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Queen's Medical Center

Collaborator

Hawaii Radiologic Associates, Ltd.

Collaborator

Source ClinicalTrials.gov
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