Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions

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Brief Title

Contrast Enhanced Endoscopic Ultrasound in Pancreas Lesions

Official Title

The Role of Contrast Enhanced Endoscopic Ultrasound for Evaluation of Pancreas Lesions

Brief Summary

      The purpose of this study is to determine whether quantitative contrast-enhanced endoscopic
      ultrasound (CE-EUS) improves the evaluation of pancreas tumors and precursor lesions,
      including cysts, compared to conventional endoscopic ultrasound.
    

Detailed Description

      The study is a prospective trial of CE- EUS in which the conventional EUS that is part of
      standard clinical care is conducted after injection of intravenous contrast agent.

      The study population will include those patients already undergoing endoscopic ultrasound for
      standard pancreatic indications at Cedars-Sinai Medical Center. The primary procedures will
      include conventional EUS to evaluate a pancreatic lesion as part of standard of care, IV
      contrast agent during the procedure if deemed necessary by the investigator, collection of
      time intensity curves for pancreas and lesions from the EUS processor. The study includes one
      standard of care visit for EUS, and the enrollment period will be 24 months. All enrolled
      patients will be followed by chart review or phone call for a period of 12 months.

      All of the subjects will be undergoing an EUS for standard of care. These patients will also
      receive an IV contrast agent (Lumason) during the procedure, which is not part of standard of
      care, and is for research use only. FNA will be performed only on those patients deemed to
      require FNA based solely on the standard EUS.

      If the aims of the study are achieved, it ill confirm that contrast-enhanced EUS can be used
      to differentiate various pancreatic lesions and, in future, may aid in risk-stratification of
      precursor lesions for pancreatic cancer.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

The results obtained by EUS versus contrast EUS to diagnose pancreas cystic lesions, mass lesion, and origin of pancreatitis.

Secondary Outcome

 Quantitative Parameters of Pancreas Lesions

Condition

Pancreatitis

Intervention

EUS enhanced with contrast to evaluate pancreas

Study Arms / Comparison Groups

 Contrast EUS
Description:  Undergoing EUS for pancreatic indication (cyst, pancreatitis, mass)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

200

Start Date

February 26, 2020

Completion Date

February 26, 2022

Primary Completion Date

February 26, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patients undergoing endoscopic ultrasound for pancreatic indications

          -  Patients must have unexplained pancreatitis, pancreas mass(es), or pancreatic cystic
             lesions or worrisome clinical, imaging or laboratory findings

        Exclusion Criteria:

          -  Patients <18 years of age, pregnant women, and lactating mothers will be excluded.

          -  Subjects with unstable cardiopulmonary condition will be excluded (acute myocardial
             infarction, acute coronary syndromes, worsening or unstable heart failure, or serious
             ventricular arrhythmias)

          -  Patients with known or suspected right-to-left, bi-directional, or transient
             right-to-left cardiac shunts will be excluded given theoretical (though clinically
             insignificant) risk of embolization

          -  Patients with a history of allergy to Lumason will be excluded
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 310 423 3872, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04324294

Organization ID

STUDY00000259


Responsible Party

Principal Investigator

Study Sponsor

Cedars-Sinai Medical Center


Study Sponsor

, , 


Verification Date

March 2020