Back to resultsHigh Resolution Ultrasound in Pancreatic Ductal Adenocarcinoma
Primary Purpose
Pancreatic Ductal Adenocarcinoma
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Ductal Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Males and females > 18 y
- PDAC diagnosed by typical imaging findings or pathology
- Scheduled for surgical resection
- Contrast enhanced CT scan performed locally at UHN
Exclusion Criteria:
1) Inability or unwillingness to provide informed consent
Sites / Locations
- University Health NetworkRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
High Resolution Ultasound
Arm Description
Diagnostic high resolution ultrasound pre-operatively and intraoperatively
Outcomes
Primary Outcome Measures
High-resolution U/S will be used to measure vascular invasion and regional lymph node metastases in PDAC
The U/S results will be compared to pre-operative CT scan to help determine the diagnostic effectiveness of High Resolution US
Secondary Outcome Measures
Full Information
NCT ID
NCT03820661
First Posted
January 11, 2019
Last Updated
April 11, 2022
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03820661
Brief Title
High Resolution Ultrasound in Pancreatic Ductal Adenocarcinoma
Official Title
Advancing The Local Staging Of Pancreatic Ductal Adenocarcinoma Through High-Resolution Ultrasound: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Ductal Adenocarcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Resolution Ultasound
Arm Type
Other
Arm Description
Diagnostic high resolution ultrasound pre-operatively and intraoperatively
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
High resolution ultrasound pre-operatively and intra-operatively
Primary Outcome Measure Information:
Title
High-resolution U/S will be used to measure vascular invasion and regional lymph node metastases in PDAC
Description
The U/S results will be compared to pre-operative CT scan to help determine the diagnostic effectiveness of High Resolution US
Time Frame
within 2 weeks of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females > 18 y
PDAC diagnosed by typical imaging findings or pathology
Scheduled for surgical resection
Contrast enhanced CT scan performed locally at UHN
Exclusion Criteria:
1) Inability or unwillingness to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Ramotar
Phone
416-946-4501
Ext
2657
Email
Stephanie.Ramotar@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Dorian Anglin Facey
Phone
416 340 4800
Ext
5095
Email
dorian.facey@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korosh Khalili, MD
Organizational Affiliation
UHN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorian Facey
Phone
4377797757
First Name & Middle Initial & Last Name & Degree
Stephanie Ramotar
First Name & Middle Initial & Last Name & Degree
Korosh Khalili
12. IPD Sharing Statement
Learn more about this trial
High Resolution Ultrasound in Pancreatic Ductal Adenocarcinoma
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