Assessment of Complete Response MRI Criterion After Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05534841

Enrollment

Registered

2022-09-10

Start date

2022-04-01

Completion date

2022-08-12

Last updated

2022-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Neoplasms

Keywords

MRI, Complete response

Brief summary

Standard care for locally advanced rectal cancer consists in a neoadjuvant therapy followed by surgery. Morbidity and mortality remain high after rectal surgery, and often linked with quality of life impairment. 10 to 30% present a pathological complete response after neoadjuvant therapy. Some surgical teams propose watch and wait approach for patients selected with clinical complete responses criterion. The problem is to be sur the response is complete. MRI seems to be accurate to select complete responders. We will try to find MRI criterion of complete responses.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Rectal adenocarcinoma * Locally advanced * Neoadjuvant therapy * MRI restaging * Rectal surgery * Definitive anatomopathology study

Design outcomes

Primary

Measure	Time frame	Description
Complete response MRI criterion	Day 0: immediately after the procedure	We selected several objective MRI criterion among literature and compared them between the two groups.

Secondary

Measure	Time frame	Description
MRI accuracy	Day 0: immediately after the procedure	Calculated Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value.

Countries

France

Outcome results