Predicting Neoadjuvant Therapy Response of Rectal Cancer With MRI

June 19, 2023 updated by: Sun Ying-Shi
The purpose of this study is to investigate if MRI scans performed after neoadjuvant radiotherapy can predict the therapeutic response of rectal cancer following preoperative chemo-radiotherapy. This will help doctors to better tailor treatments for rectal cancer in the future.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We proposed to constructed multi-parameter predictive model for predicting therapeutic response and pathological complete response(pCR) of patients with rectal cancer who received neoadjuvant chemoradiation. MR radiomics,convolutional neural networks, morphological parameters and quantitative functional parameters derived from diffusion-weighted MR images will be integrated for model construction.

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.
Interventional

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.
1614

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Peking University Cancer Hospital
      • Beijing, Beijing, China
        • Beijing Friendship Hospital Capital Medical University
      • Beijing, Beijing, China
        • Beijing Chao Yang Hospital
      • Beijing, Beijing, China
        • Chinese Academy of Medical Sciences, Cancer Hospital & Institute
    • Chongqing
      • Chongqing, Chongqing, China
        • The First Affiliated Hospital of Chongqing Medical University
    • Guangxi
      • Guilin, Guangxi, China
        • Guangxi Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Hubei Cancer Hospital
    • Hunan
      • Changsha, Hunan, China
        • Hunan Cancer Hospital
    • Jilin
      • Changchun, Jilin, China
        • Jilin Cancer Hospital
      • Changchun, Jilin, China
        • The First Affiliated Hospital of Jilin University
    • Shanxi
      • Taiyuan, Shanxi, China
        • Shanxi Cancer Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18 years
  • T3/4 or node positive biopsy-proved primary rectal cancer
  • Suitable for pre-operative chemoradiotherapy and surgical resection
  • No contraindication to MRI
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • History or concurrent of other cancer
  • Previous therapy to pelvis
  • Unable/unwilling to have MRI
  • Pacemaker or implanted defibrillator
  • Pregnancy, lactation or inadequate contraception
  • Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study
  • Unwilling or unable to give informed consent

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Assessing response with MRI

Preoperative chemo-radiotherapy as standard treatment. Neoadjuvant therapy (long course intensity modulated radio-chemotherapy, GTV 50.6Gy, totally 22 fractions; Capecitabine 825mg/m2 /bid by oral administration).

Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy.

All patients are scheduled to receive total mesorectal excision surgery 12-14 weeks after the completion of preoperative chemo-radiotherapy.
Device: three MR examination
Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy.
Other Names:
  • imaging

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
Predictive value of eary MRI (14-16 days MRI) for assessing pathological complete response(pCR) at surgery
Time Frame: 2 years
A scoring system for predicting pCR will be developed based on MRI parameters and their changes between baseline and early MRI. No viable cancer cells seen in the resection specimen is regarded as pCR
2 years
Predictive value of preoperative MRI(7-9 weeks after the completion of preoperative chemo-radiotherapy) for assessing pCR
Time Frame: 2 years
A scoring system for predicting pCR will be developed based on MRI parameters
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Predictive value of eary MRI (14-16 days after initiation of preoperative radio-chemotherapy) for assessing pathological response according to Tumour Regression Grade (TRG)
Time Frame: 2 years
A scoring system for predicting pathological response will be developed based on MRI parameters and their changes between baseline and early MRI.TRG1 is regarded as responder, and TRG2/3 is regarded as non-responder.
2 years
Feasibility of conducting MRI scans at 7-9 weeks after preoperative radio-chemotherapy
Time Frame: 2 years
This will be assessed in terms of whether MR imaging at 7-9 weeks after preoperative radio-chemotherapy adds any additional predictive value to imaging performed 14-16 days after initiation of preoperative radio-chemotherapy.
2 years
MRI-predicted pCR and MRI-predicted response on long-term disease control and survival
Time Frame: 3 years
3 years disease-free survival and overall survival will be assessed
3 years
Predictive value of preoperative MRI(7-9 weeks after the completion of preoperative chemo-radiotherapy) for assessing pathological response according to Tumour Regression Grade (TRG)
Time Frame: 2 years
A scoring system for predicting pathological response will be developed based on MRI parameters and their changes between baseline and early MRI.TRG1 is regarded as responder, and TRG2/3 is regarded as non-responder.
2 years

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.
Sun Ying-Shi

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 Chair: Ying-Shi Sun, MD, No.52 Fu Cheng Road, Hai Dian District, Beijing, 10142

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 10, 2016

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.
July 17, 2020

Study Completion (Estimated)

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.
December 31, 2023

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).
December 17, 2015

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.
December 23, 2015

First Posted (Estimated)

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.
December 29, 2015

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.
June 22, 2023

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.
June 19, 2023

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.
June 1, 2023

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.
  • PNTRRC-MRI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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