UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058773 |
|---|---|
| Receipt number | R000066731 |
| Scientific Title | Study of the relationship between FLT accumulation and thymine synthesis pathway in lung cancer using PET imaging |
| Date of disclosure of the study information | 2025/08/12 |
| Last modified on | 2025/08/12 18:48:47 |
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Basic information
Public title
Study of the relationship between FLT accumulation and thymine synthesis pathway in lung cancer using PET imaging
Acronym
Study of the relationship between FLT accumulation and thymine synthesis pathway in lung cancer using PET imaging
Scientific Title
Study of the relationship between FLT accumulation and thymine synthesis pathway in lung cancer using PET imaging
Scientific Title:Acronym
Study of the relationship between FLT accumulation and thymine synthesis pathway in lung cancer using PET imaging
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the association between different FLT and FDG-PET findings and the activation of salvage and de novo pathways of the thymine synthesis pathway in tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Association of tumor FLT and FDG accumulation with TS expression in tumors.
Key secondary outcomes
The relationship between tumor FLT accumulation, FDG accumulation, the ratio of FLT accumulation to FDG accumulation, and tumor immunostaining (Ki67, TK1, TS, GLUT1) findings and thymidine concentration in tumors.
The relationship between tumor FLT accumulation, FDG accumulation, ratio of FLT accumulation to FDG accumulation, and tumor immunostaining (Ki67, TK1, TS, GLUT1) findings and thymidine concentration in tumors and the response rate, progression-free survival, and overall survival to drug therapy including pemetrexed or S-1.
The relationship between tumor FLT accumulation, FDG accumulation, ratio of FLT accumulation to FDG accumulation, and tumor immunostaining (Ki67, TK1, TS, GLUT1) findings and thymidine concentration in the tumor and tumor histology, presence of oncogenes, and level of PD-L1 expression.
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
Patients with untreated non-small cell lung cancer confirmed by histological or cytological diagnosis, or with primary lung cancer strongly suspected by CT or FDG-PET imaging and scheduled for surgical resection.
Patients who have been fully informed about their participation in this study, and who have given written consent of their own free will based on a thorough understanding of the study.
Key exclusion criteria
1) Pregnant woman
2) Patients with metalic device in their body
3) Patients with claustrophobia
4) Patients with a long diameter of less than 2 cm of the solid component of the primary lung cancer on CT
5) Other cases attending physician it is determined unsuitable for registration of the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
University of Fukui
Division name
Department of Respiratory Medicine
Zip code
910-1193
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji, Fukui
TEL
0776-61-3111
umeda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Respiratory Medicine
Zip code
9101193
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji, Fukui
TEL
0776-61-3111
Homepage URL
umeda@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Masayuki Sato
Funding Source
Organization
MEXT KAKENHI 25K19098
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of University of Fukui
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji, Fukui
Tel
0776-61-3111
rinsho-rinri@ml.u-fukui.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 | 08 | Month | 12 | 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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2025 | Year | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066731
