- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03895177
Evaluation of Resectability of Pancreatic Cancer Using Low kVp CT
March 19, 2021 updated by: Jeong Min Lee, Seoul National University Hospital
Usefulness of Low kVp High mAs Computed Tomography for the Evaluation of Pancreatic Cancer Resectability
The aim of this study is to investigate usefulness of low kVp high mAs computed tomography in evaluation of pancreatic cancer resectability.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
147
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Anyang, Korea, Republic of, 14068
- Hallym University Sacred Heart Hospital
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Seoul, Korea, Republic of, 03722
- Severance Hospital
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Seoul, Korea, Republic of, 05505
- Asan Medical Center
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Seoul, Korea, Republic of, 08308
- Korea University Guro Hospital
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Kyung-gi Do
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Goyang-si, Kyung-gi Do, Korea, Republic of, 10408
- Korea National Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1. age between 20 year-old and 85 year-old 2. patient with pancreatic cancer detected on standard CT scan using 120 kVp that obtained within one month 3. consider surgical resection for pancreatic cancer treatment 4. patients who can undergo contrast enhanced CT scan
Exclusion Criteria:
- 1. history of severe adverse reaction to iodine contrast 2. less than 60 of estimated GFR
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: low kVp high mAs CT group
doing pancreatic CT with 80 kVp tube current with more than 500 mA tube current for the evaluation of pancreatic cancer resectability
|
pancreatic protocol CT with 80kVp tube voltage and more than 500mA tube current acquire late arterial phase and portal venous phase using volus tracking method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
accuracy of low kVp CT to assess R0 resection of pancreatic cancer
Time Frame: 2 weeks after surgery
|
Pancreastic cancer resectability
|
2 weeks after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2019
Primary Completion (Actual)
October 28, 2020
Study Completion (Anticipated)
January 31, 2022
Study Registration Dates
First Submitted
March 6, 2019
First Submitted That Met QC Criteria
March 27, 2019
First Posted (Actual)
March 29, 2019
Study Record Updates
Last Update Posted (Actual)
March 22, 2021
Last Update Submitted That Met QC Criteria
March 19, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- SNUH-2019-0140
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.