3D Modeling for Detecting Locally Advanced Rectal Cancer With Positive Circumferential Resection Margin

NCT ID: NCT07183124

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-07-31

Brief Summary

This retrospective study aims to develop an AI-assisted 3D modeling system to improve staging accuracy for stage II-III locally advanced rectal cancer (LARC). High-quality CT images from Taichung Veterans General Hospital will be used to reconstruct tumor boundaries and spatial relationships. The AI model will be trained and validated against MRI and pathology results to predict circumferential resection margin (CRM) status. Outcomes include sensitivity, specificity, accuracy, and agreement with standard imaging. This system seeks to support precise tumor staging and inform future clinical decision-making.

Conditions

General Surgery; Oncology; Medical Informatics

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

AI-Assisted 3D Imaging Model for Tumor and CRM Assessmen

This study uses an AI-assisted 3D imaging model to analyze existing CT and MRI images of stage II-III locally advanced rectal cancer patients. The system reconstructs tumor boundaries and spatial relationships, predicts circumferential resection margin (CRM) status, and supports staging assessment. No interventions are performed on participants, and all data are collected retrospectively from routine clinical care.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Diagnosed with rectal cancer, clinical stage II-III, with no distant metastasis (M0)
• Age over 18 years, with adequate physical status classified as American Society of Anesthesiologists (ASA) I-III, capable of receiving treatment and surgery
• No history of other malignancies or major diseases affecting study assessment within the past three years.
• Complete medical records, including available CT and MRI imaging.

Exclusion Criteria

• Patients with clinical stage I or IV rectal cancer.
• Age under 18 years, or physical status not meeting American Society of Anesthesiologists (ASA) I-III criteria, unable to undergo surgery or related treatment.
• Presence of other major diseases or malignancies affecting tumor assessment (e.g., diagnosis of another malignancy within the past three years, uncontrolled cardiovascular disease).
• Incomplete medical records or imaging data, including missing required CT or MRI images.

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

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: collaborator

Taichung Veterans General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taichung Veterans General Hospital

Taichung, , Taiwan

Countries

Taiwan

Central Contacts

Chun-Yu Lin, PhD

Role: CONTACT

classicpiano2003@gmail.com

886-4-23592525 ext. 5161

Other Identifiers

TCVGH-NHRI1142008

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CE25536A

Identifier Type: -

Identifier Source: org_study_id