Is 3-D Imaging Technology Superior to Computed Tomography in Assessing Response to Neoadjuvant Treatment in Patients With Borderline or Locally Advanced Pancreatic Adenocarcinoma?
Sponsor study identifier
observational
70
1 country
17
Study Start
March 21, 2024
Actual (reported)Primary Completion
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 21, 2024
Actual (reported)August 27, 2024
Actual (reported)September 3, 2024
Actual (reported)November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
To analyze the accuracy of 3D-MSP technology in evidencing response to neoadjuvant chemotherapy.
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.
Through study completion, an average of 2 months
Validate the usefulness of 3D-MSP technology for application in teaching, patient communication and surgical planning.
Through study completion, an average of 2 months
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.
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.
Patients with a diagnosis of borderline or locally advanced PAC of the head of the pancreas who have received neoadjuvant treatment in Spanish hospitals with extensive experience in the treatment of patients with adenocarcinoma of the pancreas and who are part of the pancreatic surgery research group.
Hospital General de Alicante
Alicante, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital del Mar (Barcelona)
First Submitted
August 27, 2024
First Posted
September 3, 2024
Study Start
March 21, 2024
Actual (reported)Primary Completion
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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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
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, 46010, Spain
Hospital Dr Peset
Valencia, Spain
Hospital La Fe
Valencia, Spain
Study Completion
November 30, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 11, 2026
Record last verified: 2026-09
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