Deep Learning Based MRI Radiomics in Predicting the Clinical Risk of Locally Advanced Rectal Cancer

August 10, 2025 updated by: Cai Zerong, Sixth Affiliated Hospital, Sun Yat-sen University
Neoadjuvant therapy is the standard diagnosis and treatment strategy for locally advanced rectal cancer defined by MRI in order to achieve tumor regression, thus affecting the selection of surgical strategy and circumferential margin, improving the safety of operation and the prognosis of patients. This study focused on the related clinical factors such as tumor regression before and after neoadjuvant therapy, combined with preoperative high-dimensional features such as radiomics, to predict the related factors of tumor regression of locally advanced rectal cancer, and validate it with multicenter. In order to develop an accurate model that can be applied to the real world and stratify the risk of locally advanced rectal cancer patients before treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The patients with locally advanced rectal cancer were collected retrospectively, and the relevant information such as clinical baseline characteristics, imaging data and preoperative/postoperative pathological data were collected and integrated, applying the method of deep learning to construct the model, in order to predict and evaluate the risk factors (invasion of mesorectal fascia, status of cancer nodule, long-term prognosis, tumor recurrence, etc.) which are important in clinical diagnosis and treatment. After the model was established, prospective studies were carried out to validate the model, continue training and enrich the effectiveness of the model.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A total of 136 patients (Well T-downstage: 28.68%, 39/136) were included in the training cohort and 50 (Well T-downstage: 30%, 15/50) patients in the test cohort.

Description

Inclusion Criteria:

  1. Primary rectal adenocarcinoma was diagnosed before operation
  2. Preoperative MRI staging was diagnosed as stage cT4 rectal cancer
  3. Receiving neoadjuvant therapy before operation (including but not limited to chemotherapy, radiotherapy, immunotherapy or targeted therapy, etc.)
  4. Middle and low rectal cancer (the distance between the lower margin of the tumor and the anal margin ≤ 12cm measured by MRI)
  5. Receive radical resection of rectal cancer

Exclusion Criteria:

  1. lack of clinical TNM staging information or other key clinical information about MRI
  2. the imaging quality is poor or the MRI image has artifacts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Well T-downstage
After receiving neoadjuvant therapy, the postoperative pathological stage of patients with primary cT4 rectal cancer was pT2 or less.
Poor T-downstage
After receiving neoadjuvant therapy, the postoperative pathological stage of patients with primary cT4 rectal cancer was pT3 or above.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From date of randomization until the date of death from any cause, assessed up to 120 months
Overall Survival
From date of randomization until the date of death from any cause, assessed up to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sixth Affiliated Hospital, Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Zerong Cai, MD, Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023ZSLYEC-680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Please contact us by Email

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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