Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer

April 16, 2026 updated by: Fundació d'investigació Sanitària de les Illes Balears

Randomized Multicenter Study Protocol: Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer

The aim of this study is to assess the usefulness of a mathematical model of three-dimensional image process and reconstuction (3D-IPR) as a surgical planner in locally advanced colon cancer. In addition to comparing the diagnostic accuracy of this planner with that of the CT regarding the infiltration of neighbouring structures.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients of both sexes, aged ≥18 years.
  2. Adenocarcinoma of the right, left, sigmoid and recto-sigmoid junction that have cT3 or cT4a/b according to the eighth TNM edition of the American Joint Committee on Cancer (AJCC). Pre-treatment diagnosis by imaging (CT) test.
  3. Lymph node extension: cN0, the presence of cN1/2 according to AJCC TNM 8th edition is allowed as long as they can be resected. Pretreatment diagnosis by imaging (CT) test.
  4. Patients who access and sign informed consent for the surgical intervention.

Exclusion Criteria:

  1. Suspected carcinomatosis on preoperative CT or intraoperative finding
  2. Suspected distant metastasis on preoperative CT or intraoperative finding
  3. Patients with tumors with infiltration considered to be unresectable (pre-surgical or intraoperatively), since the anatomical-pathological analysis will not be available.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D Reconstruction Group (Group B)
Group of patients in which 3D reconstruction is going to be done before surgery
Diagnostic test: 3D reconstruction
3D mathematical reconstruction from the extension CT, which is performed on all patients with colon neoplasms, to assess the location of the primary colon tumor and possible infiltration of neighboring/retroperitoneal structures.
Other Names:
  • Cella Medical Solutions
No Intervention: No 3D reconstruction group (Group A)
Group of patients in which 3D reconstruction is not going to be performed before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: 8 weeks
Proportion of patients achieving R0 resection (defined as microscopically margin-negative resection) following surgical planning with three-dimensional image post-processing reconstruction (3D-IPR) in patients with threatened surgical margins (TSM) in locally advanced colon cancer (LACC)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of minimally invasive surgical approach
Time Frame: Within 8 Weeks
Proportion of patients undergoing a minimally invasive surgical approach (laparoscopic or robotic) following preoperative planning with three-dimensional image post-processing reconstruction (3D-IPR) in patients with locally advanced colon cancer (LACC).
Within 8 Weeks
Conversion to open surgery
Time Frame: 8 Weeks
Proportion of patients requiring conversion from minimally invasive to open surgery during procedures planned with three-dimensional image post-processing reconstruction (3D-IPR) in patients with locally advanced colon cancer (LACC).
8 Weeks
Diagnostic accuracy of 3D-IPR for detection of adjacent organ infiltration (sensitivity and specificity)
Time Frame: Within 8 Weeks
Sensitivity and specificity of three-dimensional image post-processing reconstruction (3D-IPR) compared with conventional CT radiological reports for the detection of adjacent organ infiltration in patients with locally advanced colon cancer (LACC), using intraoperative findings and/or histopathological assessment as the reference standard.
Within 8 Weeks
Overall survival (OS)
Time Frame: Up to 5 years
Overall survival, defined as the time from surgery to death from any cause, in patients with locally advanced colon cancer (LACC) undergoing surgical planning with three-dimensional image post-processing reconstruction (3D-IPR).
Up to 5 years
Rate of locoregional and distant recurrence
Time Frame: Up to 5 years
Proportion of patients experiencing locoregional or distant recurrence within 5 years after surgery, confirmed by imaging studies (CT, MRI, or PET-CT) or histopathology, in patients with locally advanced colon cancer (LACC) undergoing surgical planning with three-dimensional image post-processing reconstruction (3D-IPR).
Up to 5 years
Rate of perioperative complications (Clavien-Dindo classification)
Time Frame: Within 30 days after surgery
Proportion of patients experiencing perioperative complications within 30 days after surgery, classified according to the Clavien-Dindo grading system, following surgical planning with three-dimensional image post-processing reconstruction in patients with locally advanced colon cancer.
Within 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació d'investigació Sanitària de les Illes Balears

Collaborators

Asociacion Española de Coloproctologia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB 5113/23 PI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) from this study, including clinical variables and imaging-derived measurements, will be made available to qualified researchers. IPD will not be directly posted on ClinicalTrials.gov, but may be requested from the corresponding author. A methodologically sound research proposal must be submitted and approved by the study steering committee. Data sharing will comply with all applicable data protection regulations. Once data are available, a link to the repository will be provided in the Available IPD/Information field of the record.

Researchers with a methodologically sound proposal can request access by contacting the corresponding author. Requests will be reviewed and approved by the study steering committee. Access will be granted after agreement to terms regarding confidentiality, ethical use, and compliance with data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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