Predicting Pathological Complete Response of Rectal Cancer With Magnetic Resonance(MR) Radiomics

January 31, 2019 updated by: Sun Ying-Shi

Predicting Pathological Complete Response of Rectal Cancer to Neoadjuvant Chemoradiotherapy With MR Radiomics Method

This study plans to construct a MR radiomics model for predicting pathological complete response(pCR) to neoadjuvant chemoradiotherapy(CRT) in locally advanced rectal cancer(LARC) patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We propose to develop and validate a radiomics model for individualized pCR evaluation after CRT in patients with LARC. We plan to use both pre- and post-CRT MRI data to construct the predictive radiomics model for evaluating if LARC patients achieve pCR after CRT. The ultimate aim is to select appropriate LARC patients for omission of surgery.

Study Type

Observational

Enrollment (Actual)

538

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
        • Beijing 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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

LARC patients who will undergo neoadiuvant CRT before surgery.

Description

Inclusion Criteria:

  • pathologically proved rectal cancer
  • locally advanced rectal cancer (≥T3 or N+)
  • a distance less than 12cm between the lower edge of tumor and the anal margin
  • no evidence of distant metastases
  • no prior anti-cancer therapy before treatment
  • scheduled to receive preoperative CRT

Exclusion Criteria:

  • history or concurrent of other malignancy
  • incomplete preoperative CRT
  • failed to receive surgery or unavailable pCR assessment
  • poor quality of MR images for measurement
  • patient quit

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
Intervention / Treatment
LARC-CRT
LARC patients who will receive neoadjuvant CRT before surgical resection.
Diagnostic test: pelvic MR examination
All patients will take pelvic MR examination within 1 week before CRT and within 1 week before surgery.Pre- and post-CRT MRI examinations will be performed using a 3.0 T unit (Discovery 750) using an 8-channel phased array body coil in the supine position. To reduce colonic motility, 20mg of scopolamine butylbromide will be injected intramuscularly 30 min before MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological complete response(pCR)
Time Frame: within one week after surgery
Pathological complete response was defined as the absence of viable tumor cells in the primary tumor and lymph nodes.
within one week after surgery

Collaborators and Investigators

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

Sponsor

Sun Ying-Shi

Investigators

  • Study Chair: Ying-Shi Sun, Peking University Cancer Hospital & Institute

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)

March 1, 2013

Primary Completion (Actual)

December 18, 2018

Study Completion (Actual)

January 21, 2019

Study Registration Dates

First Submitted

August 1, 2017

First Submitted That Met QC Criteria

August 1, 2017

First Posted (Actual)

August 3, 2017

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCpCR-MR-Radiomics

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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