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Evaluation of Resectability of Pancreatic Cancer Using Low kVp CT

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. Identifier: NCT03895177
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 29, 2019
Information provided by (Responsible Party):
Jeong Min Lee, Seoul National University Hospital

Brief Summary:
The aim of this study is to investigate usefulness of low kVp high mAs computed tomography in evaluation of pancreatic cancer resectability.

Condition or disease Intervention/treatment Phase
Diagnoses Disease Diagnostic Test: contrast enhanced computed tomography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Usefulness of Low kVp High mAs Computed Tomography for the Evaluation of Pancreatic Cancer Resectability
Actual Study Start Date : March 12, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

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
Diagnostic Test: contrast enhanced computed tomography
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

Primary Outcome Measures :
  1. accuracy of low kVp CT to assess R0 resection of pancreatic cancer [ Time Frame: 2 weeks after surgery ]
    Pancreastic cancer resectability

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT03895177

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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Dong Ho Lee, M.D.    82-2-2072-0348   
Contact: Jeong Min Lee, M.D.    82-2-2072-3154   
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Jeong Min Lee, Professor, Seoul National University Hospital Identifier: NCT03895177     History of Changes
Other Study ID Numbers: SNUH-2019-0140
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No