UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056876 |
|---|---|
| Receipt number | R000065005 |
| Scientific Title | A retrospective study using 18F-FDG-PET/CT for the prediction of immunotherapy-related interstitial lung disease in lung cancer. |
| Date of disclosure of the study information | 2025/01/30 |
| Last modified on | 2025/01/30 16:00:19 |
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Basic information
Public title
A multicenter retrospective study using 18F-FDG-PET/CT for the prediction of immunotherapy-related interstitial lung disease in lung cancer.
Acronym
A multicenter retrospective study using 18F-FDG-PET/CT for the prediction of immunotherapy-related interstitial lung disease in lung cancer.
Scientific Title
A retrospective study using 18F-FDG-PET/CT for the prediction of immunotherapy-related interstitial lung disease in lung cancer.
Scientific Title:Acronym
A retrospective study using 18F-FDG-PET/CT for the prediction of immunotherapy-related interstitial lung disease in lung cancer.
Region
| Japan |
Condition
Condition
Advanced or recurrent lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Immune-checkpoint inhibitors (ICIs) have greatly improved the outcome of advanced-stage lung cancer. However, ICIs can cause serious immune-related adverse events after administration, including immune-related interstitial lung disease (ICI-ILD), which is fatal and difficult to predict. We hypothesized that patients with high preexisting lung inflammation may be at higher risk of developing interstitial lung disease after ICI administration. Accordingly, we performed a single-center retrospective study that analyzed the association between FDG uptake of noncancerous lungs (defined as the lung region contralateral to the primary tumor, without metastatic lesions) in FDG-PET/CT images and the incidence of ICI-ILD. The results showed that patients with a high FDG uptake in noncancerous lung had a significantly higher incidence of ILD than those with a low FDG uptake. The purpose of this study is to clarify the reproducibility of our findings in retrospective multicenter design.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interstitial lung disease after administration of immune checkpoint inhibitors
Key secondary outcomes
Onset of any adverse event after administration of immune checkpoint inhibitors
Prognosis after administration of immune checkpoint inhibitors
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with advanced stage or recurrent lung cancer who received ICIs during January 1, 2021 to December 31, 2023 in the following facilities.
(2) FDG-PET/CT was taken within three months before ICI therapy.
Participating facilities: Niigata University Hospital, Hokkaido Cancer Center, Tohoku University Hospital, Juntendo University Hospital, St. Marianna University Hospital, Kyoto Prefectural University of Medicine
Key exclusion criteria
(1) FDG uptake on lung region was difficult to evaluate owing to massive consolidation or pleural effusion
(2) Patients with bilateral multiple primary lung cancers.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
9518510
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata City, Niigata Prefecture
TEL
025-368-9325
satoshi7@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Respiratory Medicine and Infectious Diseases
Zip code
9518510
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata City, Niigata Prefecture
TEL
025-368-9325
Homepage URL
satoshi7@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Niigata University
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata City, Niigata Prefecture
Tel
025-368-9325
sanonao@adm.niigata-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 | 01 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who meet the following criteria will be collected retrospectively.
(1) Patients with advanced or recurrent lung cancer who received ICIs.
(2) FDG-PET/CT was taken within three months before ICI therapy.
Management information
Registered date
| 2025 | Year | 01 | Month | 30 | Day |
Last modified on
| 2025 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065005
