NCT03895177

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

March 12, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

March 6, 2019

Last Update Submit

March 19, 2021

Conditions

Diagnoses Disease

Outcome Measures

Primary Outcomes (1)

  • accuracy of low kVp CT to assess R0 resection of pancreatic cancer

    Pancreastic cancer resectability

    2 weeks after surgery

Study Arms (1)

low kVp high mAs CT group

EXPERIMENTAL

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

Interventions

contrast enhanced computed tomographyDIAGNOSTIC_TEST

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

low kVp high mAs CT group

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

You may not qualify if:

  • \. history of severe adverse reaction to iodine contrast 2. less than 60 of estimated GFR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Korea National Cancer Center

Goyang-si, Kyung-gi Do, 10408, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang, 14068, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Asan medical Center

Seoul, 05505, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Study Officials

  • Jeong Min Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 29, 2019

Study Start

March 12, 2019

Primary Completion

October 28, 2020

Study Completion

January 31, 2022

Last Updated

March 22, 2021

Record last verified: 2021-03

Locations

KR(6)