Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892380
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-07
First Post:
2023-03-31
Brief Title:
The Clinical Value of an Artificial Intelligence System Using Abbreviated Protocol of Breast MRI Facilitates Classification of Breast Lessions
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
The Clinical Value of an Artificial Intelligence System Using Abbreviated Protocol of Breast MRI Facilitates Classification of Breast Lessions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 clinical work
Detailed Description:
Full sequence of MRI scan is
MR scan protocol
1 Magnetic fields and coils Use MR scanners with high fields of 15 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 15 mm and the single scan time should be 2 min
Enhancement scan Gadobutrol used as the contrast agent and the injection dose was 01 mlkg which was injected through the elbow vein at a rate of 2-3 mLs 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
MR scan protocol
1 Magnetic fields and coils Use MR scanners with high fields of 15 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 15 mm and the single scan time should be 2 min
Enhancement scan Gadobutrol used as the contrast agent and the injection dose was 01 mlkg which was injected through the elbow vein at a rate of 2-3 mLs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None