Opportunistic Breast Cancer Screening Using Non-Contrast Chest CT
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Female patients who have undergone non-contrast chest CT examination;
Participants included in the comparative analysis must have undergone at least one comparator imaging modality (mammography and/or breast MRI);
If a breast lesion is detected, it must be confirmed by pathology or clinical follow-up at least 12 months;
No prior systemic or local therapy before imaging examinations;
Disqualifiers
History of other malignancies with potential impact on breast imaging interpretation;
Participants with suspected malignant breast lesions but no confirmation;
Prior radiotherapy, chemotherapy, or immunotherapy before imaging examinations;
Imaging data that are incomplete, of poor quality, or contain significant artifacts preventing reliable analysis;
Trial population
The study population consists of female patients undergoing non-contrast chest CT scans for any clinical indication at participating institutions, with or without breast lesions detected on CT. For participants included in the comparative analysis, at least one additional breast imaging modality (mammography and/or breast MRI) must have been performed within three months of the non-contrast chest CT examination and without any intervening clinical events.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Screening performance of non-contrast chest CT for detection of breast cancer, with comparison to mammography and/or breast MRI
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.
Time frame
Up to 12 monthsSecondary outcomes
1
Performance of non-contrast chest CT for histological classification of breast cancer, with comparison to mammography and/or breast MRI
The secondary outcome is the performance of AI-assisted analysis for classifying the histological types of breast cancer on non-contrast chest CT. Histological types are defined according to the World Health Organization classification system based on histopathological examination. 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 classification performance.
Time frame
Up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov