Contrast EUS of the Pancreas
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 2/15/2018 |
| Start Date: | July 2016 |
| End Date: | April 2018 |
| Contact: | Maria Trujillo |
| Email: | mit@usc.edu |
| Phone: | 323 409 6939 |
Prospective Controlled Trial of Contrast Enhanced Endoscopic Ultrasound for Evaluation of Pancreas Lesions
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).
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).
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).
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).
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.
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