The Clinical Value of an Artificial Intelligence System Using Abbreviated Protocol of Breast MRI Facilitates Classification of Breast Lessions
NCT ID: NCT05892380
Last Updated: 2023-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
800 participants
OBSERVATIONAL
2023-07-01
2025-08-01
Brief Summary
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Detailed Description
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MR scan protocol:
1. Magnetic fields and coils: Use MR scanners with high fields of 1.5 T and above with dedicated breast coils.
2. 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.
3. 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
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Patients who were consecutively included in our hospital for breast MRI without treatment
3. Underwent preoperative full-protocol breast MRI
4. Pathological results are available, of which benign lesions can be determined by follow-up
Exclusion Criteria
2. Patients who have been received the biopsy
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Fudan University
OTHER
Responsible Party
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Yajia Gu, MD
Director of Radiology
Locations
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Fudan university Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AMRI01
Identifier Type: -
Identifier Source: org_study_id
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