RadioPathomics Artificial Intelligence Model to Predict Tumor Regression Grading in Locally Advanced Rectal Cancer

NCT ID: NCT04273451

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-10
• Study Completion Date: 2020-12-31

Brief Summary

In this study, investigators apply a radiopathomics artificial intelligence (AI) supportive model to predict neoadjuvant chemoradiotherapy (nCRT) response before the nCRT is delivered for the patients with locally advanced rectal cancer (LARC). The radiopathomics AI system predicts individual tumor regression grading (TRG) category based on each patient's radiopathomics features extracted from the Magnetic Resonance Imaging (MRI) and biopsy images. The predictive power to classify each patient into particular TRG category will be validated in this multicenter, prospective clinical study.

Detailed Description

This is a multicenter, prospective, observational clinical study for validation of a radiopathomics integrated artificial intelligence (AI) system. 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 neoadjuvant concurrent chemoradiotherapy (nCRT), total mesorectum excision (TME) surgery and adjuvant chemotherapy. Images of Magnetic Resonance Imaging (MRI) and biopsy hematoxylin & eosin (H&E) stained slides of each patient should be available before nCRT treatment. The tumor region within these images would be delineated manually by experienced radiologists and pathologists. Further, the outlined images will be presented to the radiopathomics AI system to classify each participant into particular tumor regression grading (TRG) category. Here, the American Joint Committee on Cancer and College of American Pathologist (AJCC/CAP) 4-category TRG system is served as the standard. The actual TRG category of each participant will be confirmed based on pathologic assessment after TME surgery. Through comparisons of the predicted TRG and actual TRG category, investigators calculate the prediction accuracy, specificity and sensitivity as well as the F1 score. This study is aimed to develop a reliable and robust AI system to predict pathologic TRG prior to nCRT administration, facilitating response-guided precision therapy for patients with locally advanced rectal cancer.

Conditions

Rectal Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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
• biopsy H&E stained slides are available and scanned with high resolution 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)
• insufficient imaging quality of biopsy slides imaging to delineate tumor volume or obtain measurements (e.g., tissue dissection, color anomaly)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Affiliated Hospital of Kunming Medical College.

OTHER

Sponsor Role: collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

wanxiangbo

Associate Professor of Radiation Oncology, Vice Director, Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiangbo Wan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Xinjuan Fan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sixth Affiliated Hospital, Sun Yat-sen University

Locations

the Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

The Third Affiliated Hospital of Kunming Medical College

Kunming, Yunnan, China

Site Status: RECRUITING

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiangbo Wan, MD, PhD

Role: CONTACT

wanxbo@mail.sysu.edu.cn

+86 13826017157

Xinjuan Fan, MD, PhD

Role: CONTACT

fanxjuan@mail.sysu.edu.cn

020-38254037

Facility Contacts

Xiangbo Wan, MD, PhD

Role: primary

wanxbo@mail.sysu.edu.cn

86-20-85655905

Xinjuan Fan, MD, PhD

Role: backup

fanxjuan@mail.sysu.edu.cn

020-38254037

Zhenhui Li, MD

Role: primary

lizhenhui621@163.com

+86 13698736132

Weidong Han, MD, PhD

Role: primary

hanwd@zju.edu.cn

+86 13819124503

Other Identifiers

RPAI-TRG2020

Identifier Type: -

Identifier Source: org_study_id