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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04918992
Acronym
MRI-RP-2021
Enrollment
400
Registered
2021-06-09
Start date
2021-06-22
Completion date
2024-08-01
Last updated
2021-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Cancer

Keywords

radiation proctitis, pelvic cancers, Artificial Intelligence

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTArtificial Intelligence

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

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
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

Design outcomes

Primary

MeasureTime frameDescription
The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of AI prediction system in prediction radiation proctitisbaselineThe 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

MeasureTime frameDescription
The specificity of AI prediction system in prediction radiation proctitisbaselineThe specificity of AI prediction system in identifying the radiation proctitis candidates from non-radiation proctitis individuals among pelvic cancers underwent radiotherapy

Other

MeasureTime frameDescription
The sensitivity of AI prediction system in prediction the radiation proctitis candidatesbaselineThe sensitivity of AI prediction system in identifying the radiation proctitis candidates from non-radiation proctitis individuals among pelvic cancers underwent radiotherapy

Countries

China

Contacts

Primary ContactXinjuan Fan, MD
fanxjuan@mail.sysu.edu.cn+86 13602442569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026