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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
Full sequence of MRI scan is:
MR scan protocol:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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, | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the scan time of abbreviated and full protocol | Comparison of the scan time of abbreviated and full protocol | 2 years |
| Comparison of the interpretation time of abbreviated and full protocol |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yajia Gu, MD | Contact | +8621-64175590 | cjr.guyajia@vip.163.com | |
| Tianwen Xie, MD | Contact | +8621-64175590 | 7583724@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan university Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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 |
| D017437 |
| Skin and Connective Tissue Diseases |