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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03238885
Enrollment
538
Registered
2017-08-03
Start date
2013-03-01
Completion date
2019-01-21
Last updated
2019-02-04

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

Conditions

Locally Advanced Rectal Cancer

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTpelvic MR examination

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.

Sponsors

Sun Ying-Shi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pathological complete response(pCR)within one week after surgeryPathological complete response was defined as the absence of viable tumor cells in the primary tumor and lymph nodes.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026