Opportunistic Breast Cancer Screening Using Non-Contrast Chest CT

NCT07557654 | Not Yet Recruiting

• 1 other identifier: FDBC-2026
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Breast Cancer; Opportunistic Screening; Chest Computed Tomography; Mammography; Breast Magnetic Resonance Imaging; Artificial Intelligence

Outcome Measures

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.

  Up to 12 months

Secondary Outcomes (1)

• Performance of non-contrast chest CT for histological classification of breast cancer, with comparison to mammography and/or breast MRI

  Up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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;
• Imaging data are complete and of sufficient quality for analysis.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yajia Gu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

• Chao You, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao You, MD

CONTACT

+86-021-15800780035; youchao@fudan.edu.cn

Yajia Gu, MD

CONTACT

+86-021-18017312040; guyajia@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Radiology, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)