Perfusion Assessment With Contrast-Enhanced EUS in Locally Advanced and Metastatic Pancreatic Cancer

Summary

Patients with non-resectable pancreatic cancer have a poor prognosis.The analysis of prognostic factors before treatment may be helpful in selecting appropriate candidates for chemotherapy and determining treatment strategies.

The aim of the PEACE study is to assess the vascularity of pancreatic malignant tumors using contrast-enhanced endoscopic ultrasonography and to clarify the prognostic value of tumor vascularity in patients with locally advanced and metastatic pancreatic cancer.

Conditions

• Pancreas Cancer

Interventions

DIAGNOSTIC_TEST

Endoscopic ultrasound (including fine needle aspiration)

EUS will be performed before (including EUS-FNA for confirmation of diagnosis) and 2 months after the first course of treatment. * Protocol of EUS with EUS-FNA should include linear EUS instruments with complete examinations of the pancreas. * Tumor characteristics (echogenicity, echostructure, size) will be described as well as presence/absence of power Doppler signals. * EUS-FNA will be performed in all pancreatic masses with at least four passes.

OTHER

Contrast-enhanced endoscopic ultrasound (CE-EUS)

CE-EUS will be performed during usual EUS examination before and 2 months after the first course of chemotherapy. * The starting point of the timer will be considered the moment of intravenous contrast injection (Sonovue 4.8 mL). * The whole movie (T0-T120s) will be recorded in a DICOM format on the embedded HDD of the ultrasound system, for later analysis. * All post-processing and computer analysis of digital movies will be performed within the coordinating IT Center using Vue-Box

OTHER

Endoscopic ultrasound elastography (EG-EUS)

EUS-EG will be performed during usual EUS examinations, before and 2-months after the first course of chemotherapy, with two movies of 10 seconds recorded on the embedded HDD * The region of interest for EUS-EG will be preferably larger than the focal mass. If the focal mass is larger than 3 cm, part of the mass will be included in the ROI, as well as the surrounding structures. Very large ROI for the elastography calculations will be avoided * The following pre-settings will be used in all centers: elastography color map 1, frame rejection 2, noise rejection 2, persistence 3, dynamic rage 4, smoothing 2, blend 50%. * SR and SH will be measured; with three measurements made and recorded on the embedded HDD.

DIAGNOSTIC_TEST

Contrast-enhanced computed tomography (CT)

* Contrast-enhanced computed tomography will be obtained before treatment to assess the local extension of the tumor, and presence of lymph nodes and distant metastases. * A template will be used to report the imaging results. * The template includes morphologic, arterial, venous, and extrapancreatic evaluations. * Contrast-enhanced computed tomography will be performed 2 months after the first course of chemotherapy, using the same template, in order to evaluate the tumor response. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST).

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev

  collaborator OTHER

• Iuliu Hatieganu University of Medicine and Pharmacy

  collaborator OTHER

• Central Military Hospital Bucharest

  collaborator UNKNOWN

• Ponderas Regina Maria Hospital Bucharest

  collaborator UNKNOWN

• Caritas-Krankenhaus Bad Mergentheim

  collaborator OTHER

• Helios Kliniken Meiningen

  collaborator UNKNOWN

• University of Santiago de Compostela

  collaborator OTHER

• Hospital Märkisch Oderland Wriezen/ Strausberg

  collaborator UNKNOWN

• Institut Paoli-Calmettes

  collaborator OTHER

• Ospedale San Raffaele

  collaborator OTHER

• University College London Hospitals

  collaborator OTHER

• Newcastle-upon-Tyne Hospitals NHS Trust

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Tokyo Medical University

  collaborator OTHER

• Singapore General Hospital

  collaborator OTHER

• University of Medicine and Pharmacy Craiova

  lead OTHER

Principal Investigators

• Adrian Saftoiu, MD PhD FASGE · University of Medicine and Pharmacy Craiova

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-01

Primary Completion

2023-02-28

Completion

2023-02-28