Post-radiotherapy MRI Based AI System to Predict Radiation Proctitis for Pelvic Cancers
| Registry | NCT04918992, acronym MRI-RP-2021 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 400 (Estimated) |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University (Other) |
| Conditions | Pelvic Cancer |
| Interventions | Artificial Intelligence (Diagnostic test) |
| Dates | start 2021-06-22 (estimated), primary completion 2024-06-01 (estimated), completion 2024-08-01 (estimated), first posted 2021-06-09, last updated 2021-06-09 |
| Locations | 4 sites in China |
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In this study, investigators utilize a Artificial Intelligence (AI) supportive system to predict radiation proctitis for patients with pelvic cancers underwent radiotherapy. By the system, whether the participants achieve the radiation proctitis will be identified based on the radiomics features extracted from the post radiotherapy Magnetic Resonance Imaging (MRI) . The predictive power to discriminate the radiation proctitis individuals from non-radiation proctitis patients, will be validated in this multicenter, prospective clinical study.
This is a multicenter, prospective, observational clinical study for seeking out a better way to predict the radiation proctitis in patients with pelvic cancers based on the post-radiotherapy Magnetic Resonance Imaging (MRI) data. Patients who have been pathologically diagnosed as pelvic cancers will be enrolled from the Sixth Affiliated Hospital of Sun Yat-sen University, Sir Run Run Shaw Hospital and the Third Affiliated Hospital of Kunming Medical College. Patients with pelvic cancers who received radiotherapy will be enrolled and their post-radiotherapy MRI images will be used to predict their radiation proctitis or not. The clinical symptoms, endoscopic findings, imaging and histopathology as a standard. The predictive efficacy will be tested in this multicenter, prospective clinical study.
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: * pathologically diagnosed as pelvic tumours * intending to receive or undergoing radiotherapy * MRI (high-solution T2-weighted imaging, contrast-enhanced T1-weighted imaging, and diffusion-weighted imaging are required) examination is completed after radiotherapy Exclusion Criteria: * insufficient imaging quality of MRI (e.g., lack of sequence, motion artifacts) * incomplete radiotherapy
| Facility | City | Country | Status |
|---|---|---|---|
| the Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou, Guangdong | China | |
| the Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou, Guangdong | China | |
| The Third Affiliated Hospital of Kunming Medical College | Kunming, Yunnan | China | |
| Sir Run Run Shaw Hospital | Hangzhou, Zhejiang | China |