Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients?

August 5, 2025 updated by: Fundación para la Investigación del Hospital Clínico de Valencia

Is 3-D Imaging Technology Superior to Computed Tomography in Assessing Response to Neoadjuvant Treatment in Patients With Borderline or Locally Advanced Pancreatic Adenocarcinoma?

Prospective multicenter study in which all patients with borderline or locally advanced pancreatic adenocarcioma undergoing neoadjuvant chemotherapy and surgical exploration with curative intent will be included for one year. Preoperative images by traditional CT and 3D-MSP technology will be evaluated, comparing the accuracy variables (sensitivity, specificity, predictive values, area under the curve, concordance index) of both techniques with the gold standard (results of surgery and histopathological analysis).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Neoadjuvant chemotherapy followed by surgery represents the treatment of choice for patients with borderline and locally advanced pancreatic adenocarcinoma (PAC). Despite being the diagnostic technique of choice for PAC staging, computed tomography (CT) has a very low accuracy in detecting those patients who may benefit from surgical resection after neoadjuvant chemotherapy. Consequently, the study of computerized image processing technologies is gaining importance. However, there are no prospective validation studies of these technologies to determine their usefulness in the preoperative evaluation of PCA patients undergoing neoadjuvant therapy.

A prospective multicenter study in which all patients with borderline or locally advanced PAC undergoing neoadjuvant chemotherapy and surgical exploration with curative intent will be included for one year. Preoperative images by traditional CT and 3D-MSP technology will be evaluated, comparing the accuracy variables (sensitivity, specificity, predictive values, area under the curve, concordance index) of both techniques with the gold standard (results of surgery and histopathological analysis).

A prospective, multicenter study with control group will be performed. Since this is the evaluation of a diagnostic test, it will not be necessary to randomize the patients included, since each patient will be evaluated by means of both techniques under study, thus serving as his or her own control.

Study Type

Observational

Enrollment (Estimated)

70

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

Study Contact Backup

Study Locations

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

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of borderline or locally advanced PAC of the head of the pancreas who have received neoadjuvant treatment in Spanish hospitals with extensive experience in the treatment of patients with adenocarcinoma of the pancreas and who are part of the pancreatic surgery research group.

Description

Inclusion Criteria:

- Patients with a diagnosis of borderline or locally advanced PAC of the head of the pancreas, as defined by the National Comprehensive Cancer Network (NCCN), who have received neoadjuvant treatment and who undergo surgical exploration with resective intent.

Exclusion Criteria:

  • Patients younger than 18 years of age.
  • Patients under 18 years of age.
  • Disease progression during neoadjuvant treatment.
  • No preoperative CT scan.
  • Refusal to participate in the study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case-crossover group
All patients included in the study will undergo preoperative CT (conventional protocol) and 3D-MSP reconstruction. These results will be compared with the results of the surgery and the anatomopathological study. Each patient will be evaluated by both techniques of the study, thus serving as his or her own control.
Procedure: Three dimensional imaging technology (3D-PANC MSP model)
The processing of the CT images obtained in each center for the creation of the 3D model will be performed centrally by the team of radiologists and computer scientists of the company Cella Medical Solutions. This team will be blinded to the reports of the CT scans.For each patient 4 NCCN check-lists will be filled in without knowing the result of the surgery or the AP study: 2 based on the conventional CT and two based on the 3D-MSP study.
Procedure: Computerized tomography group (conventional CT)
A multiphase CT (venous phase and pancreatographic phase) with 1mm thick slices and series of images in coronal, axial and sagittal reconstructions will be performed. This CT model will be performed at disease diagnosis and after completion of neoadjuvant chemotherapy treatment. Both CT scans will be independently reported by a radiologist from the hospital of origin. The preoperative CT scan will also be evaluated a posteriori by a radiologist from the sponsoring center with expertise in PAC. Both reports (the one from the radiologist of the center and the one from the radiologist of the sponsoring center) will be used to fill out the imaging study variables sheet based on the latest version of the NCCN 2022 guidelines. The radiologists will not know the outcome of the surgery or the anatomic pathology study at the time of the completion of the report.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the accuracy of the 3D-MSP model versus conventional CT for preoperative diagnosis of vascular involvement (venous and/or arterial) after neoadjuvant chemotherapy in patients with borderline or locally advanced PCA.
Time Frame: Through study completion, an average of 2 months
Vascular (arterial and/or venous) involvement by the tumor. The sensitivity, specificity, predictive values and area under the ROC curve of the preoperative evaluation by conventional CT and 3D-MSP model will be compared with the result of the surgery and the pathological anatomy of the tumor (gold standard).
Through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To analyze the accuracy of 3D-MSP technology in evidencing response to neoadjuvant chemotherapy.
Time Frame: Through study completion, an average of 2 months
The sensitivity, specificity, predictive values and area under the ROC curve of the preoperative evaluation by conventional CT and 3D-MSP model will be compared with the result of the surgery and the pathological anatomy of the tumor (gold standard).
Through study completion, an average of 2 months
To determine whether quantitative texture analysis (radiomics) has a higher sensitivity and specificity than CT for diagnosing vascular involvement (venous and/or arterial) in the study group.
Time Frame: Through study completion, an average of 2 months
A posteriori, a texture analysis will be performed on both tumor tissue and adjacent tissue by Cella's radiomics team. Approximately 1500 features related to intensity (histogram), shape (volume), transform-based and radial descriptors will be extracted.
Through study completion, an average of 2 months
Validate the usefulness of 3D-MSP technology for application in teaching, patient communication and surgical planning.
Time Frame: Through study completion, an average of 2 months
A multi-question, multi-response survey will be used to subjectively determine the usefulness of the 3D model. The surveys will be answered by expert pancreatic surgeons and residents who did not participate and who are unfamiliar with the outcome of the surgery and the pathological anatomy. We will evaluate 3 areas of of interest: anatomy, surgical planning, and teaching. The ability of the 3D model for patient-physician communication will also be explored. Patients visualize the traditional CT images and the 3D model after surgery by
Through study completion, an average of 2 months

Collaborators and Investigators

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

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

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 (Actual)

March 21, 2024

Primary Completion (Estimated)

December 21, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3D-PANC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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