Colon NeoplasmsNCT07528937
Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer
A study testing 3D reconstruction in people with Colon Neoplasms and Locally Advanced Colon Cancer, run by Fundació d'investigació Sanitària de les Illes Balears.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Neoplasms, Locally Advanced Colon Cancer, 3D Reconstruction
- What is being tested?
- 3D reconstruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- 3D reconstruction
- Keywords
- Locally advanced colon cancer, Colon neoplasm, 3D Reconstruction
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D reconstructionDiagnostic test
Also called Cella Medical Solutions
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: 3D reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 weeks
Secondary outcomes (6)
Rate of perioperative complications (Clavien-Dindo classification)
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.
Measured: Within 30 days after surgery
Rate of minimally invasive surgical approach
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).
Measured: Within 8 Weeks
Conversion to open surgery
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).
Measured: 8 Weeks
Diagnostic accuracy of 3D-IPR for detection of adjacent organ infiltration (sensitivity and specificity)
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.
Measured: Within 8 Weeks
Overall survival (OS)
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).
Measured: Up to 5 years
Rate of locoregional and distant recurrence
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).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colon NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes Balears
- Sponsor type
- Other government
- Collaborators
- Asociacion Española de Coloproctologia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528937
- Sponsor's protocol ID
- IB 5113/23 PI
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36709852Jeri-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.
PubMed 36974360Garcia-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.
PubMed 39699719Garcia-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.
PubMed 40783150Jeri-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.
PubMed 40365997Torres-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.
PubMed 41483146Jeri-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.
PubMed 39808969Jeri-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.
PubMed 39375653
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Study Protocol: Application of 3D Reconstruction for Preoperative Strategy of Locally Advanced Colon Cancer
- ClinicalTrials.gov ID
- NCT07528937
- Acronym / sponsor ID
- IB 5113/23 PI
- Keywords
- Locally advanced colon cancer, Colon neoplasm, 3D Reconstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Fundació d'investigació Sanitària de les Illes BalearsOther government
- Collaborators
- Asociacion Española de Coloproctologia
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Diagnostic Test: 3D reconstructionGroup of patients in which 3D reconstruction is going to be done before surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D reconstructionAlso: Cella Medical Solutions3D 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. | Diagnostic test | 3D Reconstruction Group (Group B) |
Primary outcome
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)
6 secondary outcomes
Rate of perioperative complications (Clavien-Dindo classification)
Time frame: Within 30 days after surgery
Rate of minimally invasive surgical approach
Time frame: Within 8 Weeks
Conversion to open surgery
Time frame: 8 Weeks
Diagnostic accuracy of 3D-IPR for detection of adjacent organ infiltration (sensitivity and specificity)
Time frame: Within 8 Weeks
Overall survival (OS)
Time frame: Up to 5 years
Rate of locoregional and distant recurrence
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 36709852Garcia-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.
- Background: PubMed 36974360Jeri-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.
- Background: PubMed 39699719Garcia-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.
- Background: PubMed 40783150Garcia-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.
- Background: PubMed 40365997Jeri-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.
- Background: PubMed 41483146Torres-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.
- Background: PubMed 39808969Jeri-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.
- Background: PubMed 39375653Jeri-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing 3D reconstruction in people with Colon Neoplasms and Locally Advanced Colon Cancer, run by Fundació d'investigació Sanitària de les Illes Balears.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Jeri-McFarlane, MD, PhD (+34871205000, sebastian.jeri@ssib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07528937, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.