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Is 3-D Imaging Technology Superior to Computed Tomography in Assessing Response to Neoadjuvant Treatment in Patients With Borderline or Locally Advanced Pancreatic Adenocarcinoma?
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).
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
March 21, 2024
Primary Completion Date
December 21, 2025
Completion Date
December 30, 2025
Last Updated
August 6, 2025
70
ESTIMATED participants
Three dimensional imaging technology (3D-PANC MSP model)
PROCEDURE
Computerized tomography group (conventional CT)
PROCEDURE
Lead Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
NCT05116072
NCT05821556
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04789486