- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05892380
The Clinical Value of an Artificial Intelligence System Using Abbreviated Protocol of Breast MRI Facilitates Classification of Breast Lessions
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yajia Gu, MD
- Phone Number: +8621-64175590
- Email: cjr.guyajia@vip.163.com
Study Contact Backup
- Name: Tianwen Xie, MD
- Phone Number: +8621-64175590
- Email: 7583724@qq.com
Study Locations
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-
Shanghai
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Shanghai, Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
-
Contact:
- Yajia Gu, MD
- Phone Number: +8621-64175590
- Email: cjr.guyajia@vip.163.com
-
Contact:
- Tianwen Xie, MD
- Phone Number: +8621-64175590
- Email: 7583724@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Poor MRI image quality
- Patients who have been received the biopsy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the scan time of abbreviated and full protocol
Time Frame: 2 years
|
Comparison of the scan time of abbreviated and full protocol
|
2 years
|
Comparison of the interpretation time of abbreviated and full protocol
Time Frame: 2 years
|
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.
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMRI01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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