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

NCT03513198 | Unknown DMC

• 1 other identifier: PEACE
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreas Cancer

Keywords

contrast-enhanced endoscopic ultrasound; endoscopic ultrasound elastography; tumor vascularity; prognostic

Outcome Measures

Primary Outcomes (7)

• Change of Peak Enhancement (PE) from baseline to 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

  baseline and 2 months after the first course of treatment

• Change of Wash-in Area Under the Curve (Wi-AUC) from baseline to 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

  baseline and 2 months after the first course of treatment

• change of Rise Time (RT) from baseline to 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

  baseline and 2 months after the first course of treatment

• change of mean Transit Time (mTT) from baseline to 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

  baseline and 2 months after the first course of treatment

• Change of Time To Peak (TTP) from baseline to 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

  baseline and 2 months after the first course of treatment

• Change of Wash-in Rate (WiR) from baseline to 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

  baseline and 2 months after the first course of treatment

• Change of Wash-in Perfusion Index (WiPI) from baseline to 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

  baseline and 2 months after the first course of treatment

Secondary Outcomes (3)

• Overall survival

  1 year

• Progression-free survival

  1 year

• Tumor response to treatment

  2 months after the first course of treatment

Study Arms (1)

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); Other: Contrast-enhanced endoscopic ultrasound (CE-EUS); Other: Endoscopic ultrasound elastography (EG-EUS); Diagnostic Test: Contrast-enhanced computed tomography (CT)

Interventions

Endoscopic ultrasound (including fine needle aspiration) DIAGNOSTIC_TEST

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.

Non-resectable pancreatic cancer

Contrast-enhanced endoscopic ultrasound (CE-EUS) OTHER

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

Non-resectable pancreatic cancer

Endoscopic ultrasound elastography (EG-EUS) OTHER

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.

Non-resectable pancreatic cancer

Contrast-enhanced computed tomography (CT) DIAGNOSTIC_TEST

* 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).

Non-resectable pancreatic cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• Previous chemotherapy or radiotherapy
• Resectable pancreatic tumors

Sponsors & Collaborators

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

Related Publications (10)

• Lowenfels AB, Maisonneuve P. Epidemiology and risk factors for pancreatic cancer. Best Pract Res Clin Gastroenterol. 2006 Apr;20(2):197-209. doi: 10.1016/j.bpg.2005.10.001.

  PMID: 16549324 BACKGROUND

• Folkman J. What is the evidence that tumors are angiogenesis dependent? J Natl Cancer Inst. 1990 Jan 3;82(1):4-6. doi: 10.1093/jnci/82.1.4. No abstract available.

  PMID: 1688381 BACKGROUND

• Fidler IJ, Ellis LM. The implications of angiogenesis for the biology and therapy of cancer metastasis. Cell. 1994 Oct 21;79(2):185-8. doi: 10.1016/0092-8674(94)90187-2. No abstract available.

  PMID: 7525076 BACKGROUND

• Ikeda N, Adachi M, Taki T, Huang C, Hashida H, Takabayashi A, Sho M, Nakajima Y, Kanehiro H, Hisanaga M, Nakano H, Miyake M. Prognostic significance of angiogenesis in human pancreatic cancer. Br J Cancer. 1999 Mar;79(9-10):1553-63. doi: 10.1038/sj.bjc.6690248.

  PMID: 10188906 BACKGROUND

• Saftoiu A, Vilmann P, Bhutani MS. The role of contrast-enhanced endoscopic ultrasound in pancreatic adenocarcinoma. Endosc Ultrasound. 2016 Nov-Dec;5(6):368-372. doi: 10.4103/2303-9027.190932.

  PMID: 28000627 BACKGROUND

• Yamashita Y, Ueda K, Itonaga M, Yoshida T, Maeda H, Maekita T, Iguchi M, Tamai H, Ichinose M, Kato J. Tumor vessel depiction with contrast-enhanced endoscopic ultrasonography predicts efficacy of chemotherapy in pancreatic cancer. Pancreas. 2013 Aug;42(6):990-5. doi: 10.1097/MPA.0b013e31827fe94c.

  PMID: 23851433 BACKGROUND

• Sanchez MV, Varadarajulu S, Napoleon B. EUS contrast agents: what is available, how do they work, and are they effective? Gastrointest Endosc. 2009 Feb;69(2 Suppl):S71-7. doi: 10.1016/j.gie.2008.12.004. No abstract available.

  PMID: 19179175 BACKGROUND

• Zhang X, Galardi E, Duquette M, Lawler J, Parangi S. Antiangiogenic treatment with three thrombospondin-1 type 1 repeats versus gemcitabine in an orthotopic human pancreatic cancer model. Clin Cancer Res. 2005 Aug 1;11(15):5622-30. doi: 10.1158/1078-0432.CCR-05-0459.

  PMID: 16061881 BACKGROUND

• Chauhan VP, Martin JD, Liu H, Lacorre DA, Jain SR, Kozin SV, Stylianopoulos T, Mousa AS, Han X, Adstamongkonkul P, Popovic Z, Huang P, Bawendi MG, Boucher Y, Jain RK. Angiotensin inhibition enhances drug delivery and potentiates chemotherapy by decompressing tumour blood vessels. Nat Commun. 2013;4:2516. doi: 10.1038/ncomms3516.

  PMID: 24084631 BACKGROUND

• Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.

  PMID: 10655437 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Adrian Saftoiu, MD PhD FASGE

  University of Medicine and Pharmacy Craiova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Saftoiu, MD PhD FASGE

CONTACT

+40 744 823355; adriansaftoiu@gmail.com

Irina Cazacu, MD

CONTACT

+40 785 216 587; irina.cazacu89@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: May 1, 2018
• Study Start: May 1, 2018
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share