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

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ClinicalTrials.gov Identifier: NCT03513198
Recruitment Status : Not yet recruiting
First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
Copenhagen University Hospital at Herlev
Iuliu Hatieganu University of Medicine and Pharmacy
Central Military Hospital Bucharest
Ponderas Regina Maria Hospital Bucharest
Caritas-Krankenhaus Bad Mergentheim
Helios Kliniken Meiningen
University of Santiago de Compostela
Hospital Märkisch Oderland Wriezen/ Strausberg
Institut Paoli-Calmettes
Ospedale San Raffaele
University College London Hospitals
Newcastle-upon-Tyne Hospitals NHS Trust
M.D. Anderson Cancer Center
Shengjing Hospital
Asan Medical Center
Tokyo Medical University
Singapore General Hospital
Information provided by (Responsible Party):
University of Medicine and Pharmacy Craiova

Brief 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.


Condition or disease Intervention/treatment
Pancreas Cancer Diagnostic Test: Endoscopic ultrasound (including fine needle aspiration) Other: Contrast-enhanced endoscopic ultrasound (CE-EUS) Other: Endoscopic ultrasound elastography (EG-EUS) Diagnostic Test: Contrast-enhanced computed tomography (CT)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Tumor Vascularity Depicted by Contrast-Enhanced Endoscopic Ultrasonography as a Predictor of Treatment Efficacy in Patients With Locally Advanced and Metastatic Pancreatic Cancer (PEACE)
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Non-resectable pancreatic cancer

All patients with a suspicion of pancreatic masses will undergo EUS (including EUS-FNA for confirmation of diagnosis). A positive cytological diagnosis will be taken as a final proof of malignancy of the pancreas mass. The diagnoses obtained by EUS-FNA will be further verified during a clinical follow-up of at least 6 months.

Both pancreatic adenocarcinomas and pancreatic neuroendocrine tumors will be included.

Endoscopic ultrasound (including fine needle aspiration for confirmation of diagnosis) with sequential contrast-enhanced endoscopic ultrasound and elastography endoscopic ultrasound and contrast-enhanced computed tomography will be performed before and 2 months after the first course of treatment

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).




Primary Outcome Measures :
  1. Change of Peak Enhancement (PE) from baseline to 2 months after the first course of treatment [ Time Frame: baseline and 2 months after the first course of treatment ]
    PE represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

  2. Change of Wash-in Area Under the Curve (Wi-AUC) from baseline to 2 months after the first course of treatment [ Time Frame: baseline and 2 months after the first course of treatment ]
    Wi-AUC represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

  3. change of Rise Time (RT) from baseline to 2 months after the first course of treatment [ Time Frame: baseline and 2 months after the first course of treatment ]
    RT represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

  4. change of mean Transit Time (mTT) from baseline to 2 months after the first course of treatment [ Time Frame: baseline and 2 months after the first course of treatment ]
    mTT represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

  5. Change of Time To Peak (TTP) from baseline to 2 months after the first course of treatment [ Time Frame: baseline and 2 months after the first course of treatment ]
    TTP represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

  6. Change of Wash-in Rate (WiR) from baseline to 2 months after the first course of treatment [ Time Frame: baseline and 2 months after the first course of treatment ]
    Wir represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software

  7. Change of Wash-in Perfusion Index (WiPI) from baseline to 2 months after the first course of treatment [ Time Frame: baseline and 2 months after the first course of treatment ]
    WiPI represents a TIC analysis-derived parameter, obtained from post-processing of CE-EUS recordings with a commercially available software


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
    The overall survival (OS) will be measured from the first day of chemotherapy to the date of death

  2. Progression-free survival [ Time Frame: 1 year ]
    The progression-free survival (PFS) will be measured from the first day of chemotherapy to the date of progressive disease.

  3. Tumor response to treatment [ Time Frame: 2 months after the first course of treatment ]

    Contrast-enhanced computed tomography will be performed 2 months after the first course of chemotherapy in order to evaluate the tumor response.

    Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). According to RECIST guidelines,complete response (CR) is defined as the complete disappearance of the tumor, partial response (PR) as ≥30% decrease in longest diameter (LD), progressive disease (PD) as ≥20% increase in LD, and stable disease (SD) as a decrease or increase less than PR or PD based on anatomic assessment. Patients with CR or PR will be defined as responders, whereas those with PD or SD are defined as non-responders.




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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with a confirmed diagnosis of locally advanced/metastatic pancreatic cancer (both adenocarcinoma and neuroendocrine tumors will be included)
Criteria

Inclusion Criteria:

  • Age 18 to 90 years old, men or women
  • Signed informed consent for CE-EUS, EG-EUS and FNA biopsy
  • The diagnosis of pancreatic cancer histologically confirmed by fine needle aspiration (FNA) with EUS
  • Both pancreatic adenocarcinoma and pancreatic neuroendocrine tumors will be included
  • Unresectable, locally advanced and/or metastatic disease.

Exclusion Criteria:

  • Previous chemotherapy or radiotherapy
  • Resectable pancreatic tumors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513198


Contacts
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Contact: Adrian Saftoiu, MD PhD FASGE +40 744 823355 adriansaftoiu@gmail.com
Contact: Irina Cazacu, MD +40 785 216 587 irina.cazacu89@gmail.com

Sponsors and Collaborators
University of Medicine and Pharmacy Craiova
Copenhagen University Hospital at Herlev
Iuliu Hatieganu University of Medicine and Pharmacy
Central Military Hospital Bucharest
Ponderas Regina Maria Hospital Bucharest
Caritas-Krankenhaus Bad Mergentheim
Helios Kliniken Meiningen
University of Santiago de Compostela
Hospital Märkisch Oderland Wriezen/ Strausberg
Institut Paoli-Calmettes
Ospedale San Raffaele
University College London Hospitals
Newcastle-upon-Tyne Hospitals NHS Trust
M.D. Anderson Cancer Center
Shengjing Hospital
Asan Medical Center
Tokyo Medical University
Singapore General Hospital
Investigators
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Principal Investigator: Adrian Saftoiu, MD PhD FASGE University of Medicine and Pharmacy Craiova

Publications:

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Responsible Party: University of Medicine and Pharmacy Craiova
ClinicalTrials.gov Identifier: NCT03513198     History of Changes
Other Study ID Numbers: PEACE
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Medicine and Pharmacy Craiova:
contrast-enhanced endoscopic ultrasound
endoscopic ultrasound elastography
tumor vascularity
prognostic
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases