NCT03077334

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 7, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2018

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

3.9 years

First QC Date

February 20, 2017

Last Update Submit

January 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical PET type assessed by surgeons from preoperatively preformed PET imaging

    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 Outcomes (1)

  • Number of patients with recurrence of cancer or mortality from cancer following operation

    3 years

Study Arms (2)

K-type

FDG uptake in pancreatic cancer is similar to that of kidney

Device: PET-CT

non K-type

FDG uptake in pancreatic cancer is lower than that of kidney

Device: PET-CT

Interventions

PET-CTDEVICE

PET-CT will be done before operation and that is routine treatment procedure for pancreatic cancer.

K-typenon K-type

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Tertiary Referral Hospital

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2017

First Posted

March 10, 2017

Study Start

October 7, 2014

Primary Completion

September 17, 2018

Study Completion

September 17, 2018

Last Updated

January 11, 2019

Record last verified: 2019-01

Locations