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

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.

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Key information

Conditions

Locally Advanced Rectal Cancer

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pelvic MR examination

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.

Primary outcomes

Pathological complete response(pCR)

Time frame: within one week after surgery

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

Sponsors and collaborators

Lead sponsor

Sun Ying-Shi

Other

Registry information

Official study title

Predicting Pathological Complete Response of Rectal Cancer to Neoadjuvant Chemoradiotherapy With MR Radiomics Method

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2019
First posted: Aug 3, 2017
Registry last updated: Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed