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

Sun Ying-Shi538 enrolled

Overview

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.

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

538

Conditions

Locally Advanced Rectal Cancer

Interventions

pelvic MR examinationDIAGNOSTIC_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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Pathological complete response(pCR)

Pathological complete response was defined as the absence of viable tumor cells in the primary tumor and lymph nodes.

Time frame: within one week after surgery

Data from ClinicalTrials.gov

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