Clinical trial NCT05369546: Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis
Official title: Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: H. Lee Moffitt Cancer Center and Research Institute
name: Queen's Medical Center
name: Hawaii Radiologic Associates, Ltd.
First posted: 2022-05-11
Enrollment: 600
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study 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).

Brief summary: 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.

Detailed description: Women with dense breast have not been shown to benefit by increased cancer detection of volumetric digital breast tomosynthesis (DBT) but may benefit by lower recall rates. DBT screening biopsy rates are similar to 2D digital mammography; higher for first screening exams, lower thereafter with adjustment for age and breast density. In the U.S., 71% of biopsies do not result in a breast cancer diagnosis among women ages 40-79 who undergo breast cancer screening. To address the high rate of unnecessary biopsies, an innovative way to use FDA-approved breast imaging protocols has been developed to acquire multispectral images to measure the lipid/water/protein (L/W/P) composition of suspicious breast lesions. Malignant breast tissue has unique L/W/P composition fractions when compared to normal or benign breast tissue. This proposal aims to increase biopsy yield (BI-RADS-PPV3) through combining L/W/P biological biomarkers with quantitative morphological and textural image analysis. This combination of composition and physical descriptions of suspicious breast lesions is called q3CB. The benefits of adding q3CB to the current DBT screening/diagnostic imaging paradigm, that may already include computer aided detection, is not known. This study is designed to compare the expected biopsy yield with and without q3CB in a clinical reader study and explore how q3CB may be combine with existing technologies. The central hypothesis is that biological L/W/P fractions in breast tissue in combination with analysis of morphological and textural tissue characteristics will yield significantly higher breast cancer specificity than conventional interpretation of DBT alone. 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. The investigators rationale for the proposed research is that biological L/W/P descriptions of breast lesions will lead to more specific biopsy decisions and a better understanding of cancer types. Specifically, the project aims are 1) develop q3CB lesion signatures for distinguishing breast cancer lesions from benign lesions, using 600 prospectively-acquired DBT exams of women recommended to undergo biopsy; 2) conduct a clinical reader study to compare radiologists' performance on standard-of-care FFDM or DBT without and with the inclusion of q3CB signatures; 3) Investigate the utility of q3CB lesion signatures in a screening paradigm to improve sensitivity and specificity on CADe-identified suspicious lesions in the tasks of assessing malignancy as well as in associating with their association with cancer subtypes; Exploratory) explore the added sensitivity and specificity of dual-energy DBT in phantom studies that explore lesion size, composition, and breast density. The innovation of this study is the full characterization of lipid/water/protein lesion composition with DBT and how it complements existing computer aided diagnostic programs paired with clinical radiologists providing evidence ready for clinical translation of this unique and emerging technology.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.).

Primary outcomes:
measure: Quantify biological composition of lesions
timeFrame: Baseline
measure: Quantify morphology of lesions
timeFrame: Baseline
Secondary outcomes:
measure: Comparison of radiologists' image interpretations with and without q3CB signatures
timeFrame: Baseline
measure: Sensitivity and Specificity of readers' responses for the BI-RADs assessment categories
timeFrame: Baseline
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute, Inc.
state: Florida
city: Hilo
country: United States
facility: Hawaii Radiology Associates, LTD (East Hawaii Women's Imaging Center)
state: Hawaii
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
Study officials:
affiliation: University of Hawaii Cancer Research Center
name: John A Shepherd, PhD
role: PRINCIPAL_INVESTIGATOR
References: