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

UnknownOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

May 1, 2018

Primary Completion Date

February 28, 2023

Study Completion Date

February 28, 2023

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 (1)

All Listed Sponsors
collaborator

Copenhagen University Hospital at Herlev

OTHER

collaborator

Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

collaborator

Central Military Hospital Bucharest

UNKNOWN

collaborator

Ponderas Regina Maria Hospital Bucharest

UNKNOWN

collaborator

Caritas-Krankenhaus Bad Mergentheim

OTHER

collaborator

Helios Kliniken Meiningen

UNKNOWN

collaborator

University of Santiago de Compostela

OTHER

collaborator

Hospital Märkisch Oderland Wriezen/ Strausberg

UNKNOWN

collaborator

Institut Paoli-Calmettes

OTHER

collaborator

Ospedale San Raffaele

OTHER

collaborator

University College London Hospitals

OTHER

collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

collaborator

M.D. Anderson Cancer Center

OTHER

collaborator

Shengjing Hospital

OTHER

collaborator

Asan Medical Center

OTHER

collaborator

Tokyo Medical University

OTHER

collaborator

Singapore General Hospital

OTHER

lead

University of Medicine and Pharmacy Craiova

OTHER