3D Modeling for Detecting Locally Advanced Rectal Cancer With Positive Circumferential Resection Margin
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTaichung Veterans General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
AI-Assisted 3D Imaging Model for Tumor and CRM Assessmen
Diagnostic testThis 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.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
Day 1 (At the time of retrospective imaging analysis)Secondary outcomes
1
Accuracy and agreement of AI model predictions with MRI interpretations
Agreement between AI model, MRI, and pathology results will be analyzed using Kappa statistics to evaluate consistency and reliability.
Time frame
Day 1 (At the time of retrospective imaging analysis)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Taichung Veterans General Hospital
Lead sponsor
National Health Research Institutes, Taiwan
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: