Breast CancerOPBCS-CTNCT07557654
Opportunistic Breast Cancer Screening Using Non-Contrast Chest CT
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2026to 1 May 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
Chao You, MD, +86-021-15800780035, youchao@fudan.edu.cn
Yajia Gu, MD, +86-021-18017312040, guyajia@fudan.edu.cn
About this study
Official title: Artificial Intelligence-Assisted Opportunistic Screening for Breast Cancer Using Non-Contrast Chest CT: A Comparative Study With Mammography and/or Breast MRI
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.
Read the detailed description
Breast cancer is one of the most common malignancies in women, and early detection is essential for improving clinical outcomes. While dedicated breast imaging modalities, including mammography and breast MRI, are widely used for screening. Many women undergo non-contrast chest CT scans for other clinical indications, providing a potential opportunity for breast evaluation. This observational study aims to investigate the clinical value of non-contrast chest CT scans as an opportunistic screening tool for breast cancer. Breast tissue visible on routine CT scans will be assessed using artificial intelligence-based methods to identify suspicious lesions. The primary objective is to evaluate the diagnostic performance of non-contrast chest CT in detecting breast cancer, including sensitivity, specificity, and accuracy, and to further compare its diagnostic performance with mammography and breast MRI. The findings are expected to determine whether non-contrast chest CT can serve as an opportunistic tool for early breast cancer detection without additional imaging burden, and to clarify its relative clinical value compared with established breast imaging techniques.
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Opportunistic Screening, Chest Computed Tomography, Mammography, Breast Magnetic Resonance Imaging, Artificial Intelligence
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start6 May 2026
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Cancer Hospital, Jiangsu Cancer Institute & Hospital, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University, The First Hospital of Jilin University, Affiliated Hospital of Qinghai University, People's Hospital of Ningxia Hui Autonomous Region, RenJi Hospital, Weifang Respiratory Disease Hospital
- Responsible party
- Principal investigator, Yajia Gu, MD, Fudan University
- Investigators
- Yajia Gu, MD, Principal investigator, Fudan UniversityChao You, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557654
- Sponsor's protocol ID
- FDBC-2026
- Acronym
- OPBCS-CT
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Assisted Opportunistic Screening for Breast Cancer Using Non-Contrast Chest CT: A Comparative Study With Mammography and/or Breast MRI
- ClinicalTrials.gov ID
- NCT07557654
- Acronym / sponsor ID
- OPBCS-CT / FDBC-2026
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Opportunistic Screening, Chest Computed Tomography, Mammography, Breast Magnetic Resonance Imaging, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Fujian Cancer Hospital, Jiangsu Cancer Institute & Hospital, First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University, The First Hospital of Jilin University, Affiliated Hospital of Qinghai University, People's Hospital of Ningxia Hui Autonomous Region, RenJi Hospital, Weifang Respiratory Disease Hospital
- Study start
- 6 May 2026 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer is one of the most common malignancies in women, and early detection is essential for improving clinical outcomes. While dedicated breast imaging modalities, including mammography and breast MRI, are widely used for screening. Many women undergo non-contrast chest CT scans for other clinical indications, providing a potential opportunity for breast evaluation. This observational study aims to investigate the clinical value of non-contrast chest CT scans as an opportunistic screening tool for breast cancer. Breast tissue visible on routine CT scans will be assessed using artificial intelligence-based methods to identify suspicious lesions. The primary objective is to evaluate the diagnostic performance of non-contrast chest CT in detecting breast cancer, including sensitivity, specificity, and accuracy, and to further compare its diagnostic performance with mammography and breast MRI. The findings are expected to determine whether non-contrast chest CT can serve as an opportunistic tool for early breast cancer detection without additional imaging burden, and to clarify its relative clinical value compared with established breast imaging techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Screening performance of non-contrast chest CT for detection of breast cancer, with comparison to mammography and/or breast MRI
Time frame: Up to 12 months
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.
1 secondary outcome
Performance of non-contrast chest CT for histological classification of breast cancer, with comparison to mammography and/or breast MRI
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yajia Gu, MD principal investigator
Fudan University
Chao You, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao You, MD (+86-021-15800780035, youchao@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening performance of non-contrast chest CT for detection of breast cancer, with comparison to mammography and/or breast MRI (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.