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

NCT06582342 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2025-08-06

No results posted yet for this study

Summary

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).

Conditions

  • Adenocarcinoma of the Pancreas

Interventions

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.

Sponsors & Collaborators

  • Fundación para la Investigación del Hospital Clínico de Valencia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-21
Primary Completion
2025-12-21
Completion
2025-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06582342 on ClinicalTrials.gov