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Post Radiotherapy MRI Based AI System to Predict Radiation Proctitis for Pelvic Cancers

NCT04918992 — Unknown, 400 participants, Sixth Affiliated Hospital, Sun Yat-sen University

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Post-radiotherapy MRI Based AI System to Predict Radiation Proctitis for Pelvic Cancers

RegistryNCT04918992, acronym MRI-RP-2021
StatusUnknown
Study typeObservational
Enrollment400 (Estimated)
SponsorSixth Affiliated Hospital, Sun Yat-sen University (Other)
ConditionsPelvic Cancer
InterventionsArtificial Intelligence (Diagnostic test)
Datesstart 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
Locations4 sites in China

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-Summary

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.

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+Detailed description

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.

+Arms and interventions

  • Artificial Intelligence (Diagnostic test): investigators utilize a Artificial Intelligence (AI) supportive system to predict radiation proctitis for patients with pelvic cancers underwent radiotherapy

+Outcome measures

Primary outcomes

  • The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of AI prediction system in prediction radiation proctitis [baseline]: The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of AI prediction system in identifying the radiation proctitis candidates from non-radiation proctitis individuals among pelvic cancers underwent radiotherapy

Secondary outcomes

  • The specificity of AI prediction system in prediction radiation proctitis [baseline]: The specificity of AI prediction system in identifying the radiation proctitis candidates from non-radiation proctitis individuals among pelvic cancers underwent radiotherapy

Other outcomes

  • The sensitivity of AI prediction system in prediction the radiation proctitis candidates [baseline]: The sensitivity of AI prediction system in identifying the radiation proctitis candidates from non-radiation proctitis individuals among pelvic cancers underwent radiotherapy

+Eligibility

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

+Locations (4)

FacilityCityCountryStatus
the Sixth Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, GuangdongChina
the Sixth Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, GuangdongChina
The Third Affiliated Hospital of Kunming Medical CollegeKunming, YunnanChina
Sir Run Run Shaw HospitalHangzhou, ZhejiangChina

+Investigators

  • Xinjuan Fan, MD, Study chair, Sixth Affiliated Hospital, Sun Yat-sen University
  • Weidong Han, MD, Principal investigator, Sir Run Run Shaw Hospital
  • Zhenhui Li, MD, Principal investigator, The Third Affiliated Hospital of Kunming Medical College.

My Notes