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

NCT06582342 | Recruiting

• 1 other identifier: 3D-PANC
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 17

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).

Conditions

Adenocarcinoma of the Pancreas

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Procedure: Three dimensional imaging technology (3D-PANC MSP model); Procedure: Computerized tomography group (conventional CT)

Interventions

Three dimensional imaging technology (3D-PANC MSP model) PROCEDURE

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.

Case-crossover group

Computerized tomography group (conventional CT) PROCEDURE

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.

Case-crossover group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (17)

Hospital General de Alicante

Alicante, Spain

RECRUITING

Hospital Universitario de Badajoz

Badajoz, Spain

RECRUITING

Hospital del Mar (Barcelona)

Barcelona, 08003, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, Spain

RECRUITING

Hospital de Bellvitge

Barcelona, Spain

RECRUITING

Hospital German Trias y Puyol

Barcelona, Spain

RECRUITING

Hospital Nuestra señora de la Candelaria

Candelaria, Spain

RECRUITING

Hospital General de Castellón

Castellon, Spain

RECRUITING

Hospital Carlos Haya

Málaga, Spain

RECRUITING

Hospital Virgen de la Victoria

Málaga, Spain

RECRUITING

Hospital Virgen de la Arrixaca

Murcia, Spain

RECRUITING

Hospital Son Espases Palma de Mallorca

Palma de Mallorca, Spain

RECRUITING

Hospital Virgen del Rocío

Seville, Spain

RECRUITING

Hospital Juan XXIII Tarragona

Tarragona, Spain

RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

RECRUITING

Hospital Dr Peset

Valencia, Spain

RECRUITING

Hospital La Fe

Valencia, Spain

RECRUITING

MeSH Terms

Interventions

Congresses as Topic

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Central Study Contacts

Dimitri Dorcaratto

CONTACT

675441388; dorcaratto.dimitri@gmail.com

Marina Garcés

CONTACT

marinagarcesalbir@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 3, 2024
• Study Start: March 21, 2024
• Primary Completion: December 21, 2025
• Study Completion: December 30, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (17)