NCT07528937

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
61mo left

Started May 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2031

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

March 23, 2026

Last Update Submit

April 16, 2026

Conditions

Colon NeoplasmsLocally Advanced Colon Cancer3D Reconstruction

Keywords

Locally advanced colon cancerColon neoplasm3D Reconstruction

Outcome Measures

Primary Outcomes (1)

  • R0 resection rate

    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 Outcomes (6)

  • Rate of perioperative complications (Clavien-Dindo classification)

    Within 30 days after surgery

  • Rate of minimally invasive surgical approach

    Within 8 Weeks

  • Conversion to open surgery

    8 Weeks

  • Diagnostic accuracy of 3D-IPR for detection of adjacent organ infiltration (sensitivity and specificity)

    Within 8 Weeks

  • Overall survival (OS)

    Up to 5 years

  • +1 more secondary outcomes

Study Arms (2)

No 3D reconstruction group (Group A)

NO INTERVENTION

Group of patients in which 3D reconstruction is not going to be performed before surgery

3D Reconstruction Group (Group B)

EXPERIMENTAL

Group of patients in which 3D reconstruction is going to be done before surgery

Diagnostic Test: 3D reconstruction

Interventions

3D reconstructionDIAGNOSTIC_TEST

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.

Also known as: Cella Medical Solutions
3D Reconstruction Group (Group B)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of both sexes, aged ≥18 years.
  • 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.
  • 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.
  • Patients who access and sign informed consent for the surgical intervention.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Garcia-Granero A, Jeri Mc-Farlane S, Gamundi Cuesta M, Gonzalez-Argente FX. Application of 3D-reconstruction and artificial intelligence for complete mesocolic excision and D3 lymphadenectomy in colon cancer. Cir Esp (Engl Ed). 2023 May;101(5):359-368. doi: 10.1016/j.cireng.2023.01.006. Epub 2023 Jan 26.

    PMID: 36709852BACKGROUND

  • Jeri-McFarlane S, Garcia-Granero A, Ochogavia-Segui A, Pellino G, Oseira-Reigosa A, Gil-Catalan A, Brogi L, Ginard-Vicens D, Gamundi-Cuesta M, Gonzalez-Argente FX. Three-dimensional modelling as a novel interactive tool for preoperative planning for complex perianal fistulas in Crohn's disease. Colorectal Dis. 2023 Jun;25(6):1279-1284. doi: 10.1111/codi.16539. Epub 2023 Mar 27.

    PMID: 36974360BACKGROUND

  • Garcia-Granero A, Jeri-McFarlane S, Torres-Mari N, Brogi L, Ferra-Canet M, Navarro Zoroa MA, Gamundi-Cuesta M, Gonzalez-Argente FX. 3D-reconstruction printed models and virtual reality improve teaching in oncological colorectal surgery. Tech Coloproctol. 2024 Dec 19;29(1):24. doi: 10.1007/s10151-024-03074-3.

    PMID: 39699719BACKGROUND

  • Garcia-Granero A, Jeri-McFarlane S, Ochogavia A, Gamundi-Cuesta M, Garcia-Granero E, Gonzalez-Argente FX. 3D reconstructions in rectal cancer. New tools for better diagnosis and surgical planning. Cir Esp (Engl Ed). 2025 Sep;103(9):800198. doi: 10.1016/j.cireng.2025.800198. Epub 2025 Aug 7.

    PMID: 40783150BACKGROUND

  • Jeri-McFarlane S, Garcia-Granero A, Ochogavia-Segui A, Ginard-Vicens D, Brogi L, Ferra-Canet M, Gamundi-Cuesta M, Gonzalez-Argente FX. 3D-reconstruction printed models could enhance understanding of Crohn's disease complex perianal fistulas? ANZ J Surg. 2025 Nov;95(11):2359-2366. doi: 10.1111/ans.70140. Epub 2025 May 14.

    PMID: 40365997BACKGROUND

  • Torres-Mari N, Garcia-Fuster AG, Jeri-McFarlane S, Ochogavia-Segui A, Diaz-Ferrando J, Gomez-Gomes G, Gamundi-Cuesta M, Gonzalez-Argente FX. Anatomy-guided computational framework for classifying vascular ligation and lymphadenectomy in oncologic sigmoidectomy: toward AI-supported surgical auditing. Int J Colorectal Dis. 2026 Jan 3;41(1):12. doi: 10.1007/s00384-025-05046-x.

    PMID: 41483146BACKGROUND

  • Jeri-McFarlane S, Garcia-Granero A, Martinez-Ortega MA, Amengual-Antich I, Robayo AR, Gamundi-Cuesta M, Gonzalez-Argente FX. Tailored-surgery for locally advanced colon cancer based on 3D mathematical reconstruction surgical planner: Observational comparative non-randomized study. Eur J Surg Oncol. 2025 Feb;51(2):109584. doi: 10.1016/j.ejso.2025.109584. Epub 2025 Jan 6.

    PMID: 39808969BACKGROUND

  • Jeri-McFarlane S, Garcia-Granero A, Pellino G, Torres-Mari N, Ochogavia-Segui A, Rodriguez-Velazquez M, Gamundi-Cuesta M, Gonzalez-Argente FX. Prospective observational non-randomized trial protocol for surgical planner 3D image processing & reconstruction for locally advanced colon cancer. BMC Surg. 2024 Oct 7;24(1):292. doi: 10.1186/s12893-024-02558-1.

    PMID: 39375653BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Sebastian Jeri-McFarlane, MD, PhD

CONTACT

+34871205000sebastian.jeri@ssib.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2026

First Posted

April 14, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2031

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.