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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
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
Conditions
Interventions
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.
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