Radiomics-based Artificial Intelligence System to Predict Neoadjuvant Treatment Response in Rectal Cancer

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Sixth Affiliated Hospital, Sun Yat-sen University
Updated on 19 February 2024
cancer
metastasis
adenocarcinoma
MRI
chemoradiotherapy
fluorouracil
adjuvant therapy
adjuvant chemotherapy
rectal cancer
adenocarcinoma of rectum
adjuvant

Summary

In this study, investigators utilize a radiomics prediction model to predict the tumor response to neoadjuvant chemoradiotherapy (nCRT) before the nCRT is administered for patients with locally advanced rectal cancer (LARC). Previously, the radiomics prediction model has been constructed based on the radiomics features extracted from pretreatment Magnetic Resonance Imaging (MRI) in the training set, and optimized in the external validation set. The predictive power of this radiomics prediction model to discriminate the pathologic complete response (pCR) patients from non-pCR individuals, will be further verified in this prospective, multicenter clinical study.

Description

This is a multicenter, prospective, observational clinical study for validation of a radiomics-based artificial intelligence (AI) prediction model. Patients who have been pathologically diagnosed as rectal adenocarcinoma and defined as clinical II-III staging without distant metastasis will be enrolled from the Sixth Affiliated Hospital of Sun Yat-sen University, the Third Affiliated Hospital of Kunming Medical College and Sir Run Run Shaw Hospital Affiliated by Zhejiang University School of Medicine. All participants should follow a standard treatment protocol, including concurrent neoadjuvant chemoradiotherapy (nCRT), total mesorectum excision (TME) surgery and adjuvant chemotherapy. Enhanced Magnetic Resonance Imaging (MRI) examination should be completed before the administration of nCRT treatment. The tumor volumes at high solution T2-weighted, contrast-enhanced T1-weighted and diffusion weighted images will be manually delineated, respectively. The outlined MRI images will be captured by the radiomics prediction model to generate a predicted response ("predicted pCR" vs. "predicted non-pCR") of each patient, whereas the true response ("confirmed pCR" vs. "confirmed non-pCR") is derived from pathologic reports after TME surgery serving as the gold standard for evaluation. The prediction accuracy, specificity, sensitivity and Area Under Curve (AUC) of Receiver Operating Characteristic (ROC) curves will be calculated. This study is aimed to provide a reliable and accurate AI system to predict the pathologic tumor response to nCRT before its administration, which might facilitate the identification of pCR candidates for further precision therapy among patients with locally advanced rectal cancer.

Details
Condition Colorectal Cancer, Colorectal Cancer, Rectal Cancer, Rectal Cancer
Age 18years - 75years
Clinical Study IdentifierNCT04273477
SponsorSixth Affiliated Hospital, Sun Yat-sen University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

pathologically diagnosed as rectal adenocarcinoma
defined as clinical II-III staging (T3, and/or positive nodal status) without distant metastasis by enhanced Magnetic Resonance Imaging (MRI)
intending to receive or undergoing neoadjuvant concurrent chemoradiotherapy (5-fluorouracil based chemotherapy, given orally or intravenously; Intensity-Modulated Radiotherapy or Volume-Modulated Radiotherapy delivered at 50 gray (Gy) in gross tumor volume (GTV) and 45 Gy in clinical target volume (CTV) by 25 fractions)
intending to receive total mesorectum excision (TME) surgery after neoadjuvant therapy (not completed at the enrollment), and adjuvant chemotherapy
MRI (high-solution T2-weighted imaging, contrast-enhanced T1-weighted imaging, and diffusion-weighted imaging are required) examination is completed before the neoadjuvant chemoradiotherapy

Exclusion Criteria

with history of other cancer
insufficient imaging quality of MRI to delineate tumor volume or obtain measurements (e.g., lack of sequence, motion artifacts)
incomplete neoadjuvant chemoradiotherapy
no surgery after neoadjuvant chemoradiotherapy resulting in lack of pathologic assessment of tumor response
tumor recurrence or distant metastasis during neoadjuvant chemoradiotherapy
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Results (3 sites found)
  • 1

    the Sixth Affiliated Hospital of Sun Yat-sen University

    China

  • 2

    The Third Affiliated Hospital of Kunming Medical College

    China

  • 3

    Sir Run Run Shaw Hospital

    China

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