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

Last updated: August 30, 2024
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Adenocarcinoma

Treatment

Computerized tomography group (conventional CT)

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

Clinical Study ID

NCT06582342
3D-PANC
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a diagnosis of borderline or locally advanced PAC of the head of thepancreas, as defined by the National Comprehensive Cancer Network (NCCN), who havereceived neoadjuvant treatment and who undergo surgical exploration with resectiveintent.

Exclusion

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.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Computerized tomography group (conventional CT)
Phase:
Study Start date:
March 21, 2024
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Hospital General de Alicante

    Alicante,
    Spain

    Active - Recruiting

  • Hospital Universitario de Badajoz

    Badajoz,
    Spain

    Active - Recruiting

  • Hospital Clínic de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital German Trias y Puyol

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital de Bellvitge

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital del Mar (Barcelona)

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Nuestra señora de la Candelaria

    Candelaria,
    Spain

    Active - Recruiting

  • Hospital General de Castellón

    Castelló de la Plana,
    Spain

    Active - Recruiting

  • Hospital Virgen de la Arrixaca

    Murcia,
    Spain

    Active - Recruiting

  • Hospital Carlos Haya

    Málaga,
    Spain

    Active - Recruiting

  • Hospital Virgen de la Victoria

    Málaga,
    Spain

    Active - Recruiting

  • Hospital Son Espases Palma de Mallorca

    Palma De Mallorca,
    Spain

    Active - Recruiting

  • Hospital Virgen del Rocío

    Sevilla,
    Spain

    Active - Recruiting

  • Hospital Juan XXIII Tarragona

    Tarragona,
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

  • Hospital Dr Peset

    Valencia,
    Spain

    Active - Recruiting

  • Hospital La Fe

    Valencia,
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.