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RECRUITING
NCT06582342

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

Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

70

Start Date

2024-03-21

Completion Date

2025-12-30

Last Updated

2025-08-06

Healthy Volunteers

No

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.

Locations (17)

Hospital General de Alicante

Alicante, Spain

Hospital Universitario de Badajoz

Badajoz, Spain

Hospital del Mar (Barcelona)

Barcelona, Spain

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital de Bellvitge

Barcelona, Spain

Hospital German Trias y Puyol

Barcelona, Spain

Hospital Nuestra señora de la Candelaria

Candelaria, Spain

Hospital General de Castellón

Castellon, Spain

Hospital Carlos Haya

Málaga, Spain

Hospital Virgen de la Victoria

Málaga, Spain

Hospital Virgen de la Arrixaca

Murcia, Spain

Hospital Son Espases Palma de Mallorca

Palma de Mallorca, Spain

Hospital Virgen del Rocío

Seville, Spain

Hospital Juan XXIII Tarragona

Tarragona, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Hospital Dr Peset

Valencia, Spain

Hospital La Fe

Valencia, Spain