Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients?
NCT ID: NCT06582342
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
70 participants
OBSERVATIONAL
2024-03-21
2025-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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Case-crossover group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients under 18 years of age.
* Disease progression during neoadjuvant treatment.
* No preoperative CT scan.
* Refusal to participate in the study.
18 Years
ALL
No
Sponsors
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Fundación para la Investigación del Hospital Clínico de Valencia
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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3D-PANC
Identifier Type: -
Identifier Source: org_study_id
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