Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients?
- Conditions
- Adenocarcinoma of the Pancreas
- Interventions
- Procedure: Three dimensional imaging technology (3D-PANC MSP model)Procedure: Computerized tomography group (conventional CT)
- Registration Number
- NCT06582342
- Lead Sponsor
- Fundaci贸n para la Investigaci贸n del Hospital Cl铆nico 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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
- Arm && Interventions
Group Intervention Description Case-crossover group Three dimensional imaging technology (3D-PANC MSP model) All patients included in the study will undergo preoperative CT (conventional protocol) and 3D-MSP reconstruction. These results will be compared with the results of the surgery and the anatomopathological study. Each patient will be evaluated by both techniques of the study, thus serving as his or her own control. Case-crossover group Computerized tomography group (conventional CT) All patients included in the study will undergo preoperative CT (conventional protocol) and 3D-MSP reconstruction. These results will be compared with the results of the surgery and the anatomopathological study. Each patient will be evaluated by both techniques of the study, thus serving as his or her own control.
- 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 de Bellvitge
馃嚜馃嚫Barcelona, Spain
Hospital General de Alicante
馃嚜馃嚫Alicante, Spain
Hospital Universitario de Badajoz
馃嚜馃嚫Badajoz, Spain
Hospital del Mar (Barcelona)
馃嚜馃嚫Barcelona, Spain
Hospital German Trias y Puyol
馃嚜馃嚫Barcelona, Spain
Hospital Cli虂nic de Barcelona
馃嚜馃嚫Barcelona, Spain
Hospital Nuestra se帽ora de la Candelaria
馃嚜馃嚫Candelaria, Spain
Hospital General de Castell贸n
馃嚜馃嚫Castell贸 de la Plana, Spain
Hospital Virgen de la Arrixaca
馃嚜馃嚫Murcia, Spain
Hospital Carlos Haya
馃嚜馃嚫M谩laga, Spain
Hospital Virgen de la Victoria
馃嚜馃嚫M谩laga, Spain
Hospital Son Espases Palma de Mallorca
馃嚜馃嚫Palma De Mallorca, Spain
Hospital Dr Peset
馃嚜馃嚫Valencia, Spain
Hospital La Fe
馃嚜馃嚫Valencia, Spain
Hospital Virgen del Roc铆o
馃嚜馃嚫Sevilla, Spain
Hospital Juan XXIII Tarragona
馃嚜馃嚫Tarragona, Spain
Hospital Cl铆nico Universitario de Valencia
馃嚜馃嚫Valencia, Spain