Breast CancerNCT05892380
The Clinical Value of an Artificial Intelligence System Using Abbreviated Protocol of Breast MRI Facilitates Classification of Breast Lessions
An observational study of Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study aims to use a combination of abbreviated protocol and artificial intelligence to automatically identify lesions and make diagnosis without decreasing the diagnostic accuracy of breast cancer, thus enhancing the comfort of patient examination, accelerating the flow of examination and reducing the load of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Aug 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- Adult, Older adult
Study population: The statistical analyses in this study were all descriptive, without any predefined hypotheses. Referring to a recent study* of artificial intelligence combined with abbreviated protocol MRI to classify benign and malignant non-mass-enhancing lesions in the breast*, a sample size of 800 cases was taken, which would require 800 patients to be enrolled, based on at least one lesion at the initial consultation of one patient.
Who may be able to join
- Patients with breast lesions detected by ultrasound and mammography that cannot be characterized
- Patients who were consecutively included in our hospital for breast MRI without treatment
- Underwent preoperative full-protocol breast MRI
- Pathological results are available, of which benign lesions can be determined by follow-up
Who cannot join
- Poor MRI image quality
- Patients who have been received the biopsy
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan university Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Yajia Gu, MD, +8621-64175590, cjr.guyajia@vip.163.com
Tianwen Xie, MD, +8621-64175590, 7583724@qq.com
About this study
This study aims to use a combination of abbreviated protocol and artificial intelligence to automatically identify lesions and make diagnosis without decreasing the diagnostic accuracy of breast cancer, thus enhancing the comfort of patient examination, accelerating the flow of examination and reducing the load of clinical work.
Read the detailed description
Full sequence of MRI scan is:
MR scan protocol:
- Magnetic fields and coils: Use MR scanners with high fields of 1.5 T and above with dedicated breast coils.
- Scanning position: prone position with bilateral breasts naturally draped over the center of the breast coil. The position should ensure that all breast tissue is located in the coil, the skin and breast are not folded, the bilateral breast is symmetrical, the nipple is perpendicular to the ground, and the midline of the sternum is located in the middle line of the coil.
- Scanning sequence and parameters: T1WI non-fat suppressed sequence, T2WI fat suppressed sequence, dynamic five-phase enhanced T1WI fat suppressed sequence, and diffusion weighted imaging (DWI); delayed sagittal T1W1 fat suppressed sequence.
Imaging parameters: the thickness of the scanned layer should be ≤3 mm, the resolution within the layer should be <1.5 mm, and the single scan time should be <2 min.
Enhancement scan: Gadobutrol used as the contrast agent, and the injection dose was 0.1 ml/kg, which was injected through the elbow vein at a rate of 2-3 mL/s using a pressure syringe, and 10-20 mL of saline was injected into the tube at the same rate after the contrast agent injection. The T1WI sequences before and after enhancement were preferably fat-suppressed and bilateral mammary glands were imaged simultaneously, and subtraction treatment was recommended. The recommended duration of delayed enhancement scan is 7 min, not less than 5 min.
Abbreviated sequences : T1WI + dynamic enhanced T1 phase I + maximum density projection images generated by automatic reconstruction in three directions. No extra sequences are required.
By adding artificial inteeligence, a diagnostic performance comparable with full sequences is expected.
- Conditions
- Breast Cancer
- Keywords
- Artificial intelligence, Breast cancer, Magnetic resonance imaging, Maximum intensity projection, Abbreviated protocol
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between the diagnostic performance of【AP breast MRI + AI】 vs. 【Radiologist】, using the pathological results as golden standard,
Comparison of AUC, sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) between【AP breast MRI + AI】 vs. 【Radiologist】, using the pathological results as golden standard,
Measured: 2 years
Secondary outcomes (2)
Comparison of the scan time of abbreviated and full protocol
Comparison of the scan time of abbreviated and full protocol
Measured: 2 years
Comparison of the interpretation time of abbreviated and full protocol
Comparison of the interpretation time of abbreviated and full protocol. Although abbreviated saves scan time, the interpretation time may increase because the usage of AI.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (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
- 800 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Yajia Gu, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892380
- Sponsor's protocol ID
- AMRI01
- Status last verified
- May 2023
- First submitted
- 31 Mar 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Value of an Artificial Intelligence System Using Abbreviated Protocol of Breast MRI Facilitates Classification of Breast Lessions
- ClinicalTrials.gov ID
- NCT05892380
- Acronym / sponsor ID
- AMRI01
- Conditions
- Breast Cancer
- Keywords
- Artificial intelligence, Breast cancer, Magnetic resonance imaging, Maximum intensity projection, Abbreviated protocol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 7 Jun 2023 (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.
This study aims to use a combination of abbreviated protocol and artificial intelligence to automatically identify lesions and make diagnosis without decreasing the diagnostic accuracy of breast cancer, thus enhancing the comfort of patient examination, accelerating the flow of examination and reducing the load of clinical work.
Detailed description
Full sequence of MRI scan is:
MR scan protocol:
- Magnetic fields and coils: Use MR scanners with high fields of 1.5 T and above with dedicated breast coils.
- Scanning position: prone position with bilateral breasts naturally draped over the center of the breast coil. The position should ensure that all breast tissue is located in the coil, the skin and breast are not folded, the bilateral breast is symmetrical, the nipple is perpendicular to the ground, and the midline of the sternum is located in the middle line of the coil.
- Scanning sequence and parameters: T1WI non-fat suppressed sequence, T2WI fat suppressed sequence, dynamic five-phase enhanced T1WI fat suppressed sequence, and diffusion weighted imaging (DWI); delayed sagittal T1W1 fat suppressed sequence.
Imaging parameters: the thickness of the scanned layer should be ≤3 mm, the resolution within the layer should be <1.5 mm, and the single scan time should be <2 min.
Enhancement scan: Gadobutrol used as the contrast agent, and the injection dose was 0.1 ml/kg, which was injected through the elbow vein at a rate of 2-3 mL/s using a pressure syringe, and 10-20 mL of saline was injected into the tube at the same rate after the contrast agent injection. The T1WI sequences before and after enhancement were preferably fat-suppressed and bilateral mammary glands were imaged simultaneously, and subtraction treatment was recommended. The recommended duration of delayed enhancement scan is 7 min, not less than 5 min.
Abbreviated sequences : T1WI + dynamic enhanced T1 phase I + maximum density projection images generated by automatic reconstruction in three directions. No extra sequences are required.
By adding artificial inteeligence, a diagnostic performance comparable with full sequences is expected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The statistical analyses in this study were all descriptive, without any predefined hypotheses. Referring to a recent study* of artificial intelligence combined with abbreviated protocol MRI to classify benign and malignant non-mass-enhancing lesions in the breast*, a sample size of 800 cases was taken, which would require 800 patients to be enrolled, based on at least one lesion at the initial consultation of one patient.
Key inclusion criteria (4 listed)
- Patients with breast lesions detected by ultrasound and mammography that cannot be characterized
- Patients who were consecutively included in our hospital for breast MRI without treatment
- Underwent preoperative full-protocol breast MRI
- Pathological results are available, of which benign lesions can be determined by follow-up
Key exclusion criteria (2 listed)
- Poor MRI image quality
- Patients who have been received the biopsy
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
Comparison between the diagnostic performance of【AP breast MRI + AI】 vs. 【Radiologist】, using the pathological results as golden standard,
Time frame: 2 years
Comparison of AUC, sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) between【AP breast MRI + AI】 vs. 【Radiologist】, using the pathological results as golden standard,
2 secondary outcomes
Comparison of the scan time of abbreviated and full protocol
Time frame: 2 years
Comparison of the interpretation time of abbreviated and full protocol
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yajia Gu, MD (+8621-64175590, cjr.guyajia@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between the diagnostic performance of【AP breast MRI + AI】 vs. 【Radiologist】, using the pathological results as golden standard, (time frame: 2 years). 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 7 Jun 2023.