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Trial record 3 of 131 for:    Pancreatic Cancer | ( Map: South Korea )

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

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ClinicalTrials.gov Identifier: NCT03077334
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment
Pancreatic Cancer Device: PET-CT

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oncologic Outcomes Based on Clinical Pattern of Preoperative PET-CT in Resected Pancreatic Cancer-Prospective Cohort Study
Actual Study Start Date : October 7, 2014
Actual Primary Completion Date : September 17, 2018
Actual Study Completion Date : September 17, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of patients with recurrence of cancer or mortality from cancer following operation [ Time Frame: 3 years ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Tertiary Referral Hospital
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03077334


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

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03077334     History of Changes
Other Study ID Numbers: 4-2014-0702
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases