Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pelvic MRI for establishing new mrTRG method | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- rectal cancer with NAT
- description
- The patients are planned to receive neoadjvant therapy, and then receive radical surgery.
- interventionNames
- Diagnostic Test: pelvic MRI for establishing new mrTRG method
Primary outcomes (1)
- measure
- pathological tumor regression grade(pTRG)
- timeFrame
- within 2 weeks after surgery
- description
- pTRG is evaluated according to the AJCC system. pTRG0-1 is defined as good response, pTRG2 as moderate response, and pTRG3 as poor response. The pTRG is judged by two experienced pathologists working together. If there are any discrepancies, then a third senior pathologist is consulted for arbitration. there were any discrepancies, then a third senior pathologist was consulted. there were any discrepancies, then a third senior pathologist was consulted.
Secondary outcomes (3)
- measure
- distant metastasis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * biopsy-proved primary rectal cancer * baseline MRI confirmed LARC (cT3 and/or cN+) * scheduled to take neoadjuvant therapy * receive baseline and preoperative pelvic MRI * receive TME surgery after NAT * have routine follow-up after the operation Exclusion Criteria: * history of malignancy or multiple primary cancers * receive surgery directly without NAT * don't receive TME surgery * don't complete NAT * simultaneous distant metastasis at the baseline diagnosis * lack of baseline or preoperative pelvic MRI * incomplete or unavailable pathological information * lost to follow-up within three months after surgery (lost since the first follow-up visit)
References
Publications (0)
Data not yet available