UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047230 |
|---|---|
| Receipt number | R000053865 |
| Scientific Title | Treatment effect and prediction survival of Immune checkpoint inhibitors by FDG-PET: A multicenter prospective study |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2022/03/20 07:59:59 |
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Basic information
Public title
Treatment effect and prediction survival of Immune checkpoint inhibitors by FDG-PET/CT: A multicenter study
Acronym
Treatment effect and prediction survival of Immune checkpoint inhibitors by PET: A multicenter study
Scientific Title
Treatment effect and prediction survival of Immune checkpoint inhibitors by FDG-PET: A multicenter prospective study
Scientific Title:Acronym
Treatment effect and prediction survival of Immune checkpoint inhibitors by PET: A multicenter prospective study
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To inspect whether FDG-PET/CT can become the useful imaging biomarker in an effect prediction and the effect measurement of the checkpoint inhibitor treatment of immunity by multicenter prospective study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Right curative effect judgment best overall response which stands on the progress in various indexes (if before treatment checkpoint inhibitor treatment of immunity ago rate of change after two cycles, three ways after two cycles) such as the texture analysis (Entropy, Homogeneity, Dissimilarity, Intensity variability, Size-zone variability, Zone percentage) to express SUVmax, SUVmean, SUVpeak, SULpeak, MTV (metabolic tumor volume), TLG (total lesion glycolysis) which are a fixed-quantity level of the PET, inhomogeneity of the accumulation, and totals it clinically, and is judged: I investigate the useful index that can predict BOR (Responder vs. non-responder), convalescence (Progression free survival: PFS and Overall survival: the OS), the onset of side effect (thyroidal dysfunction, stroma-related pneumonia, exanthem, colitis) and perform the construction of the nomogram predicting outcome using a meaningful factor provided for a multivariate analysis of the survival analysis.
Key secondary outcomes
With a curative effect judgment (with EORTC classification and PERCIST classification imPERCIST classification) of the PET when compared after two cycles if was before treatment a curative effect judgment (RECIST1.1 classification and irRECIST classification and iRECIST classification) of the CT compare it, and inspect neither difference. I inspect whether a difference is reflected on PFS and the OS in Responder group (CR or CMR+PMR) and Non-responder group (PMR+SMD+PMD or SMD+PMD).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
To perform an examination for FDG-PET/CT after start of therapy two cycles of the immune checkpoint inhibitor targeting at patients with lung cancer in three institutions.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The one that fulfills all the following conditions
-The which the chief physician made checkpoint inhibitor start of therapy of immunity, and judged an examination for FDG-PET/CT after two cycles if necessary
-The person who received an examination for FDG-PET/CT before checkpoint inhibitor start of therapy of immunity
- one 20 years or older
- The good one where is from head to foot in a state
- The one where treatment is planned sequentially in each facility
- Outpatient department, hospitalization, the sex do not matter
- The one where I can understand study contents, and a written agreement is provided
Key exclusion criteria
- That cannot keep a posture of facing upward because of pains in succession for around 30 minutes
- During the pregnancy or pregnancy with the possibility
- The extreme claustrophobia
- The one where progress after treatment being refused, and curing became unidentified
- In addition, the person who judges that a manager for study is inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kitajima |
Organization
Hyogo College of Medicine
Division name
Radiology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
TEL
0798-45-6883
kazu10041976@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Kitajima |
Organization
Hyogo College of Medicine
Division name
Radiology
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
TEL
0798-45-6883
Homepage URL
kazu10041976@yahoo.co.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kindai University, Osaka university, Gunma Prefectural College of Health Science
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Hyogo Medical University Ethics Review Committee
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
Tel
0798-45-6006
rinri@hyo-med.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
近畿大学附属病院（大阪府）、大阪大学附属病院（大阪府）、群馬県立県民健康科学大学（群馬県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 01 | 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
| 2022 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 20 | Day |
Last modified on
| 2022 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053865
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/03/21 | documents.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/03/21 | 多施設研究実施研究計画書案.doc |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/03/21 | 説明文書3.doc |
