NCT05374044

Establishment of MRI Model for pTRG in Rectal Cancer With Establishment of

Establishment of a Quantified Imaging Method for Evaluating Tumor Response Grade in Rectal Cancer Patient With Neoadjuvant Therapy: a Multi-center Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 385 (actual)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study proposeto integrate a variety of imaging quantitative indicators to establish a new MRI-based tumor response regression(mrTRG) classification method. The accuracy of the established mrTRG classification method according pathology TRG(pTRG) will be tested. The ability of the established mrTRG classification method to predict prognosis will also be tested.

Detailed description

The study included two part: one is a retrospective single-center cohort for analyzing quantitative MRI factors associated with pTRG, from which a new MRI-based tumor response regression(mrTRG) classification method will be established. The other is a prospective multi-center cohort for testing the accuracy of the established mrTRG classification according to pTRG; and also for validating the established mrTRG classification associated with survival.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	pelvic MRI for establishing new mrTRG method	they will received two pelvic MR examinations before and after neoadjvant therapy. The MRI before neoadjvant therapy is considered as baseline MRI, which is usually taken within 3 weeks before NAT. The MRI after neoadjvant therapy is considered as preoperative MRI, which is usually taken within 3-8 weeks before NAT.

Timeline

• Start date: 2020-05-18
• Primary completion: 2023-04-30
• Completion: 2025-12-31
• First posted: 2022-05-13
• Last updated: 2023-06-22

Locations

3 sites across 1 country: China