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

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Enrolling

Conditions: Adenocarcinoma of the Pancreas

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

Study type: Observational

Funder types: Other

Identifiers

NCT06582342

3D-PANC

Details and patient eligibility

About

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).

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

70 participants in 1 patient group

Case-crossover group

Description:

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.

Treatment:

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

Procedure: Computerized tomography group (conventional CT)