Evaluation of Resectability of Pancreatic Cancer Using Low kVp CT

Sponsor

Seoul National University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03895177

Collaborator

(none)

147

Enrollment

Locations

Arm

34.7

Anticipated Duration (Months)

24.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

147 participants

Allocation:

N/A

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 :

Mar 12, 2019

Actual Primary Completion Date :

Oct 28, 2020

Anticipated Study Completion Date :

Jan 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

accuracy of low kVp CT to assess R0 resection of pancreatic cancer [2 weeks after surgery]
Pancreastic cancer resectability

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea National Cancer Center	Goyang-si	Kyung-gi Do	Korea, Republic of	10408
2	Hallym University Sacred Heart Hospital	Anyang		Korea, Republic of	14068
3	Seoul National University Hospital	Seoul		Korea, Republic of	03080
4	Severance Hospital	Seoul		Korea, Republic of	03722
5	Asan medical Center	Seoul		Korea, Republic of	05505
6	Korea University Guro Hospital	Seoul		Korea, Republic of	08308

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Jeong Min Lee, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeong Min Lee, Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT03895177

Other Study ID Numbers:

SNUH-2019-0140

First Posted:

Mar 29, 2019

Last Update Posted:

Mar 22, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 22, 2021