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High Resolution Ultrasound in Pancreatic Ductal Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820661
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:
Pancreatic cancer patients at UHN who have had a CT at UHN and have surgery planned will undergo a high resolution ultrasound pre-operatively and intra-operatively. This study is being done to see if using high resolution ultrasound before and during surgery will help the doctors accurately diagnose pancreatic ductal adenocarcinoma and identify if the disease has spread to other areas of the body.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Device: Ultrasound Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Advancing The Local Staging Of Pancreatic Ductal Adenocarcinoma Through High-Resolution Ultrasound: A Pilot Study
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arms and Interventions
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Arm Intervention/treatment
High Resolution Ultasound
Diagnostic high resolution ultrasound pre-operatively and intraoperatively
 Device: Ultrasound
High resolution ultrasound pre-operatively and intra-operatively


Outcome Measures
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Primary Outcome Measures :
  1. High-resolution U/S will be used to measure vascular invasion and regional lymph node metastases in PDAC [ Time Frame: within 2 weeks of surgery ]
    The U/S results will be compared to pre-operative CT scan to help determine the diagnostic effectiveness of High Resolution US


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females > 18 y
  2. PDAC diagnosed by typical imaging findings or pathology
  3. Scheduled for surgical resection
  4. Contrast enhanced CT scan performed locally at UHN

Exclusion Criteria:

1) Inability or unwillingness to provide informed consent

Contacts and Locations
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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): NCT03820661


Contacts
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Contact: Stephanie Ramotar 416-946-4501 ext 2657 Stephanie.Ramotar@uhn.ca
Contact: Dorian Anglin Facey 416 340 4800 ext 5095 dorian.facey@uhn.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Dorian Facey    4377797757      
Contact: Stephanie Ramotar         
Principal Investigator: Korosh Khalili         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Korosh Khalili, MD UHN
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03820661    
Other Study ID Numbers: 18-5982
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms