Contrast EUS of the Pancreas

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Brief Title

Contrast EUS of the Pancreas

Official Title

Prospective Controlled Trial of Contrast Enhanced Endoscopic Ultrasound for Evaluation of Pancreas Lesions

Brief Summary

      RATIONALE: Endoscopic Ultrasound (EUS) is the leading method to evaluate the pancreas but
      there may be difficulty characterizing small lesions, tumors which are not adenocarcinomas
      and neoplasia in the setting of pancreatitis.

      INTERVENTION: The innovation in this project will be the addition of intravenous contrast to
      standard EUS examination if the pancreas.

      PURPOSE: The aim is to determine if contrast enhances the ability of EUS to accurately
      diagnose lesions and target biopsies, and to define the quantitative features of this method.

      STUDY POPULATION:The population will include patients with pancreas cysts, masses, and
      inflammation presenting for EUS as part of standard clinical care.

      METHODOLOGY: This will be a prospective tandem trial involving conventional EUS, followed by
      EUS with contrast, followed by subsequent quantitative processing of contrast EUS imaging.

      ENDOINTS:Study endpoints will include the yield contrast EUS to evaluate pancreas cysts,
      masses, and inflammation. The impact of contrast EUS to better target the FNA of the chosen
      lesion will be assessed. Intra and interobserver variability will be assessed by comparing
      conventional EUS and contrast EUS of each case in a random order (intraobserver agreement)
      and among a group of blinded endosonographers (interobserver agreement).
    

Detailed Description

      AIM Early detection of pancreas cancer and precursors lesions improves survival. The
      investigators aim is to gauge whether quantitative contrast endoscopic ultrasound (EUS)
      improves the evaluation of pancreas tumors and precursors lesions including cysts.

      DESIGN The study will be a prospective tandem contrast EUS trial. All EUS will be performed
      as part of standard clinical care.

      Conventional EUS Standard EUS will first be performed using the 180 series linear array
      echoendoscope (Olympus, Center Valley, PA). The alpha-10 image processor (Aloka America,
      Wallingford, CT) in B mode will be used to acquire images. A research coordinator will help
      to record key parameters. Thirty second cine clips of conventional EUS images will be
      captured to compare with contrast EUS clips and enable intra and interobserver variability
      comparison.

      Contrast Administration Definity contrast will be activated by 45 seconds of agitation
      (VialMix, Lantheus, North Billerica, MA) and injected through the intravenous peripheral line
      which is placed to administer fluids. The investigators will administer a bolus dose of
      10microliter (microL)/kg within 30-60 seconds followed by 10ml of saline flush. Up to 2 bolus
      injections will be administered during each case and doppler sonography will be used between
      them to induce microbubble destruction.

      Contrast EUS: Following contrast administration prospective assessment will be performed
      using the Olympus endoscope and images processed using the Alpha 10 system. Harmonic
      detection conversion software installed on the alpha 10 processor to enable detection. Core
      parameters for comparison to conventional EUS will be captured prospectively.

      Quantitative Processing: For each bolus 30 seconds of cine imaging will be captured for post
      processing and for comparison with conventional EUS imaging (intra and interobserver
      variability). Images of the lesion (5mm x 5mm region) and adjacent normal tissue (5mm x 5mm)
      regions will be captured to facilitate quantitative assessment. Quantitative analytic
      software will then be used to generate time intensity curves and associated values including
      peak intensity (PI), time to peak (TTP), wash-in-slope (WIS), rise time (RT), mean transit
      time (MTT), and time from peak to one-half (TPH).

      DRUG/DEVICE INFORMATION

      Definity: Definity is an intravenous contrast agent. It is comprised of 1.1-3.3um micropheres
      containing perflutren (octafluoropropane) which is cleared by respiration.

      The gas is encapsulated lipid shells which are metabolized to free fatty acids and
      hepatically cleared.

      The Olympus 180 linear echoendoscope will be used in all procedures which are being done for
      standard clinical indications. The Aloka SSD-Alpha 10-Processor will be used for image
      capture. Post EUS quantitative processing will be performed using QLAB quantification
      software (Philips Healthcare, Bothel, WA).
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Targeting of FINE NEEDLE ASPIRATION (FNA) of pancreas lesions.

Condition

Pancreatic Neoplasms

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

Other

Estimated Enrollment

150

Start Date

July 2016

Completion Date

April 2020

Primary Completion Date

April 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Patients undergoing endoscopic ultrasound for standard pancreatic indications.

          -  Patients must have unexplained pancreatitis, pancreas mass(es), or pancreatic cystic
             lesions (>1cm or worrisome features on imaging).

        Exclusion Criteria:

          -  Patients <18 years of age, pregnant women, and lactating mothers will be excluded.
             Subjects with unstable ischemic disease will be excluded. Additionally, those 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 an allergy to Definity will be excluded.
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

, 323 409 6939, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02863770

Organization ID

HS-15-00784


Responsible Party

Principal Investigator

Study Sponsor

University of Southern California


Study Sponsor

, , 


Verification Date

May 2019