Clinical trial · Observational
Opportunistic Breast Cancer Screening Using Non-Contrast Chest CT
Artificial Intelligence-Assisted Opportunistic Screening for Breast Cancer Using Non-Contrast Chest CT: A Comparative Study With Mammography and/or Breast MRI
- 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 goal of this observational study is to evaluate the feasibility and effectiveness of using non-contrast chest computed tomography scans for opportunistic breast cancer screening, and to further compare its diagnostic performance with conventional imaging modalities, including mammography and/or breast magnetic resonance imaging.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Screening performance of non-contrast chest CT for detection of breast cancer, with comparison to mammography and/or breast MRI
- timeFrame
- Up to 12 months
- description
- The primary outcome is the screening performance of AI-assisted analysis for the detection of breast cancer on non-contrast chest CT. The detection process is conducted in a stepwise approach, involving lesion identification followed by classification into benign or malignant categories for breast cancer detection. Performance metrics include sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and area under the receiver operating characteristic curve. Participants included in the comparative analysis must have undergone at least one comparator imaging modality (mammography and/or breast MRI) within three months of the chest CT examination, with no intervening clinical events. Performance metrics will be further compared with those obtained from mammography and/or breast MRI within the same participants to evaluate the relative screening performance.
Secondary outcomes (1)
- measure
- Performance of non-contrast chest CT for histological classification of breast cancer, with comparison to mammography and/or breast MRI
- timeFrame
- Up to 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients who have undergone non-contrast chest CT examination; 2. Participants included in the comparative analysis must have undergone at least one comparator imaging modality (mammography and/or breast MRI); 3. If a breast lesion is detected, it must be confirmed by pathology or clinical follow-up at least 12 months; 4. No prior systemic or local therapy before imaging examinations; 5. Imaging data are complete and of sufficient quality for analysis. Exclusion Criteria: 1. History of other malignancies with potential impact on breast imaging interpretation; 2. Participants with suspected malignant breast lesions but no confirmation; 3. Prior radiotherapy, chemotherapy, or immunotherapy before imaging examinations; 4. Imaging data that are incomplete, of poor quality, or contain significant artifacts preventing reliable analysis; 5. Time interval between non-contrast chest CT and comparator imaging modalities exceeding three months, or with clinical events occurring between examinations that may alter lesion status.
References
Publications (0)
Data not yet available