UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058113 |
|---|---|
| Receipt number | R000066419 |
| Scientific Title | Clinical impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography in the patients with pancreatic ductal adenocarcinoma treated with neoadjuvant therapy |
| Date of disclosure of the study information | 2025/06/07 |
| Last modified on | 2025/06/07 12:26:14 |
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Basic information
Public title
Clinical impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography in the patients with pancreatic ductal adenocarcinoma treated with neoadjuvant therapy; Japan-Korea Collaborative Research
Acronym
Clinical impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography in the patients with pancreatic ductal adenocarcinoma treated with neoadjuvant therapy
Scientific Title
Clinical impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography in the patients with pancreatic ductal adenocarcinoma treated with neoadjuvant therapy
Scientific Title:Acronym
Clinical impact of 18F-fluorodeoxyglucose positron emission tomography/computed tomography in the patients with pancreatic ductal adenocarcinoma treated with neoadjuvant therapy
Region
| Japan | Asia(except Japan) |
Condition
Condition
pancreatic ductal adenocarcinoma
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to determine whether FDG-PET/CT is useful for evaluating the biological activity of PDAC after neoadjuvant therapy and for guiding decisions on curative resection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative Overall Survival
Key secondary outcomes
Recurrence-free survival, Rate of early recurrence, Pattern of recurrence
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who underwent pancreatectomy with curative intent between January 1, 2017, and December 31, 2021
2. Patients diagnosed with invasive pancreatic ductal adenocarcinoma
3. Patients who received neoadjuvant therapy prior to curative resection
4. Patients who underwent FDG-PET/CT before curative resection
Key exclusion criteria
1. Patients under 18 years of age at the time of surgery
2. Patients who declined to participate in the study
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Ikenaga |
Organization
Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Fukuoka, Japan
TEL
092-642-5441
ikenaga.naoki.533@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ikenaga |
Organization
Kyushu University
Division name
Department of Surgery and Oncology
Zip code
812-8582
Address
3-1-1 Maidashi, Fukuoka, Japan
TEL
092-642-5441
Homepage URL
ikenaga.naoki.533@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Hepato-Biliary-Pancreatic Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Kyushu University Hospital
Address
3-1-1 Maidashi, Fukuoka, Japan
Tel
092-642-5082
ijkseimei@jimu.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
885
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Overview
The standard treatment for invasive pancreatic ductal adenocarcinoma (PDAC) is curative resection following neoadjuvant therapy. While the decision to proceed with curative surgery is traditionally based on anatomical assessment using CT imaging, incorporating an evaluation of the tumor's biological activity is becoming increasingly important. FDG-PET/CT is a diagnostic tool that detects glucose uptake in cells, and the standardized uptake value (SUVmax) reflects the metabolic activity of the tumor. This study aims to analyze the association between the metabolic activity of PDAC, as assessed by FDG-PET/CT, and postoperative outcomes. The goal is to evaluate whether FDG-PET/CT can serve as a useful adjunct in determining the appropriateness of curative resection.
Management information
Registered date
| 2025 | Year | 06 | Month | 07 | Day |
Last modified on
| 2025 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066419
