Oncologic Outcomes Based on Clinical Pattern of Preoperative PET-CT in Resected Pancreatic Cancer

January 9, 2019 updated by: Yonsei University

Oncologic Outcomes Based on Clinical Pattern of Preoperative PET-CT in Resected Pancreatic Cancer-Prospective Cohort Study

The 18F-FDG-PET scan is currently being used for cancer diagnosis, staging, identifying hidden metastasis, and assessment of treatment responses in clinical oncology. Although there are important studies suggesting potential associations between PET-based parameters and oncologic outcomes, the calculation and official documentation of individual PET-based parameters might not be routine in clinical practice because these processes usually require time- and labor-consuming processes for the radiologists. In this study, the investigators prospectively determined clinical 18F-FDG-PET type according to degree of FDG-uptake in pancreatic cancer and compare oncologic outcomes between the types.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Tertiary Referral Hospital

Description

Inclusion Criteria:

  • Candidate for radical pancreatectomy due to pancreatic cancer without neoadjuvant treatment
  • Age between 20 years old and 80 years old
  • General performance status greater than 70
  • Results of peroperative PET-CT available

Exclusion Criteria:

  • Unresectable, locally advance and metastatic pancreatic cancer
  • Patients not wanting operation
  • ASA score of greater than 3
  • History of chronic alcoholism ot drug abuse
  • Lack of patient compliance
  • Patients not agreeing to enroll in the study.
  • Patients unable to understand and sign the study agreement.
  • History of neoadjuvant treatment

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
K-type
FDG uptake in pancreatic cancer is similar to that of kidney
Device: PET-CT
PET-CT will be done before operation and that is routine treatment procedure for pancreatic cancer.
non K-type
FDG uptake in pancreatic cancer is lower than that of kidney
Device: PET-CT
PET-CT will be done before operation and that is routine treatment procedure for pancreatic cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical PET type assessed by surgeons from preoperatively preformed PET imaging
Time Frame: 1 week after surgery
Three surgeons will review the preoperative PET imaging and each will determine the clinical PET type as either K-type or Non-K type. Inter-surgeon agreement of clinical PET type will be determined. Clinicopathologic characteristics between K-type and Non-K type will also be analyzed.
1 week after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with recurrence of cancer or mortality from cancer following operation
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

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)

October 7, 2014

Primary Completion (ACTUAL)

September 17, 2018

Study Completion (ACTUAL)

September 17, 2018

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (ACTUAL)

March 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 9, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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