ClinicalTrials.gg
Status unknownNCT04918992MRI-RP-2021Updated Jun 9, 2021

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

An observational study in Pelvic Cancer, sponsored by Sixth Affiliated Hospital, Sun Yat-sen University. Status unknown at 4 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-09.

Sponsored by Sixth Affiliated Hospital, Sun Yat-sen University · Observational

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Pelvic Cancer

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Keywords

  • radiation proctitis
  • pelvic cancers
  • Artificial Intelligence
03

In context

Pelvic Neoplasms

82 studies on the registry are indexed under Pelvic Neoplasms; 28 are open to participants now.

This study's planned enrollment of 400 is above the median of 167 across 31 observational studies indexed under Pelvic Neoplasms.

Browse Pelvic Neoplasms studies →

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University is the lead sponsor of 217 studies on the registry; 111 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

pelvic cancers who underwent radiotherapy will be enrolled in our study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion Criteria:

  • insufficient imaging quality of MRI (e.g., lack of sequence, motion artifacts)
  • incomplete radiotherapy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testArtificial Intelligence

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

06

What researchers measure

Primary outcomes

  1. The area under curve (AUC) of Receiver Operating Characteristic (ROC) curves of AI prediction system in prediction radiation proctitis

    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

    Time frame: baseline

Secondary outcomes

  1. The specificity of AI prediction system in prediction radiation proctitis

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

    Time frame: baseline

Other outcomes

  1. The sensitivity of AI prediction system in prediction the radiation proctitis candidates

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

    Time frame: baseline

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Study locations

4 sites
  • the Sixth Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510000, China
    • Xinjuan Fan, MD · Contact
  • the Sixth Affiliated Hospital of Sun Yat-sen University
    GuangZhou, Guangdong 510655, China
  • The Third Affiliated Hospital of Kunming Medical College
    Kunming, Yunnan 650000, China
  • Sir Run Run Shaw Hospital
    HangZhou, Zhejiang 310000, China
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jun 2021; primary completion for Jun 2024, 35 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2021
First posted
Jun 9, 2021
StartEst.
Jun 22, 2021
Primary completionEst.
Jun 1, 2024
CompletionEst.
Aug 1, 2024
Last update
Jun 9, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04918992
Responsible party
Sponsor
First posted
Jun 9, 2021
Start date
Jun 22, 2021 (estimated)
Primary completion
Jun 1, 2024 (estimated)
Completion
Aug 1, 2024 (estimated)
Last update
Jun 9, 2021

Study contacts

Xinjuan Fan, MD
Contact
fanxjuan@mail.sysu.edu.cn
+86 13602442569
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.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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