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

NCT07183124 | Not Yet Recruiting

• 2 other identifiers: CE25536ATCVGH-NHRI1142008
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Keywords

rectal cancer; 3D Modeling; deep learning; Pelvic CT Imaging; Clinical Prediction Model

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the AI-assisted 3D imaging model for predicting circumferential resection margin (CRM) negativity

  Model predictions are compared with pathology results (gold standard) to assess diagnostic accuracy.

  Day 1 (At the time of retrospective imaging analysis)

Secondary Outcomes (1)

• Accuracy and agreement of AI model predictions with MRI interpretations

  Day 1 (At the time of retrospective imaging analysis)

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (≥18 years) diagnosed with stage II-III locally advanced rectal cancer (LARC) without distant metastasis (M0), who received care at Taichung Veterans General Hospital (TVGH), Taiwan. Eligible participants have adequate physical status (ASA I-III) to undergo standard treatment and surgery, no history of other malignancies or major diseases affecting tumor assessment within the past three years, and complete medical records including CT and MRI imaging. Patients with stage I or IV disease, insufficient physical status, major comorbidities, or incomplete imaging/medical records are excluded.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Chun-Yu Lin, PhD

CONTACT

886-4-23592525; classicpiano2003@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

TW (1)