Clinical trial · Observational
Lesion Composition and Quantitative Imaging Analysis on Breast Cancer Diagnosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| q3CB | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Quantify biological composition of lesions
- timeFrame
- Baseline
- description
- Quantify the biological composition (lipid/water/protein) of suspicious lesions.
- measure
- Quantify morphology of lesions
- timeFrame
- Baseline
- description
- Quantify morphology/texture (radiomics) of suspicious lesions.
Secondary outcomes (2)
- measure
- Comparison of radiologists' image interpretations with and without q3CB signatures
- timeFrame
- Baseline
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.).
References
Publications (0)
Data not yet available