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

Recruiting

• Conditions: Adenocarcinoma of the Pancreas

• Registration Number: NCT06582342
• Lead Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

Brief 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).

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 Timeline

• Study Start: 2024-03-21
• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-30
• Last Update Submitted: 2024-08-30
• Study First Posted: 2024-09-03
• Last Update Posted: 2024-09-03
• Primary Completion: 2025-03-21
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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).

Secondary Outcome Measures

Name	Time	Method
To analyze the accuracy of 3D-MSP technology in evidencing response to neoadjuvant chemotherapy.	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).
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.	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.
Validate the usefulness of 3D-MSP technology for application in teaching, patient communication and surgical planning.	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

Trial Locations

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; 🇪🇸 Castelló de la Plana, Spain

Hospital Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Carlos Haya; 🇪🇸 Málaga, Spain

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