Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients?
NCT Number: NCT06582342
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Adenocarcinoma of the Pancreas
Interventions: PROCEDURE: Three dimensional imaging technology (3D-PANC MSP model)|PROCEDURE: Computerized tomography group (conventional CT)
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-03-21
Completion Date: 2025-06-30
Locations: Hospital General de Alicante, Alicante, Spain|Hospital Universitario de Badajoz, Badajoz, Spain|Hospital del Mar (Barcelona), Barcelona, 08003, 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, Castelló de la Plana, Spain|Hospital Virgen de la Arrixaca, Murcia, Spain|Hospital Carlos Haya, Málaga, Spain|Hospital Virgen de la Victoria, Málaga, Spain|Hospital Son Espases Palma de Mallorca, Palma De Mallorca, Spain|Hospital Virgen del Rocío, Sevilla, Spain|Hospital Juan XXIII Tarragona, Tarragona, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain|Hospital Dr Peset, Valencia, Spain|Hospital La Fe, Valencia, Spain

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).

Primary Outcome Measures: 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., 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: To analyze the accuracy of 3D-MSP technology in evidencing response to neoadjuvant chemotherapy., 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., 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., 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