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

NCT ID: NCT03238885

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 538 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-01
• Study Completion Date: 2019-01-21

Brief Summary

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.

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.

Conditions

Locally Advanced Rectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

LARC-CRT

LARC patients who will receive neoadjuvant CRT before surgical resection.

pelvic MR examination

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Ying-Shi

OTHER

Sponsor Role: lead

Responsible Party

Sun Ying-Shi

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ying-Shi Sun

Role: STUDY_CHAIR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

RCpCR-MR-Radiomics

Identifier Type: -

Identifier Source: org_study_id