Clinical trial NCT06582342: Is the 3D-PANC MSP Model Superior to CT for Assessing Response to Neoadjuvant Treatment in PCA Patients?
Official title: Is 3-D Imaging Technology Superior to Computed Tomography in Assessing Response to Neoadjuvant Treatment in Patients With Borderline or Locally Advanced Pancreatic Adenocarcinoma?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenocarcinoma of the Pancreas
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: Through study completion, an average of 2 months
Secondary outcomes:
measure: To analyze the accuracy of 3D-MSP technology in evidencing response to neoadjuvant chemotherapy.
timeFrame: Through study completion, an average of 2 months
measure: 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.
timeFrame: Through study completion, an average of 2 months
measure: Validate the usefulness of 3D-MSP technology for application in teaching, patient communication and surgical planning.
timeFrame: Through study completion, an average of 2 months
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Badajoz
country: Spain
facility: Hospital Universitario de Badajoz
city: Barcelona
country: Spain
facility: Hospital del Mar (Barcelona)
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Barcelona
country: Spain
facility: Hospital German Trias y Puyol
city: Candelaria
country: Spain
facility: Hospital Nuestra señora de la Candelaria
city: Castelló de la Plana
country: Spain
facility: Hospital General de Castellón
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Carlos Haya
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria
city: Palma De Mallorca
country: Spain
facility: Hospital Son Espases Palma de Mallorca
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Tarragona
country: Spain
facility: Hospital Juan XXIII Tarragona
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Dr Peset
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
References: