UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057052 |
|---|---|
| Receipt number | R000065209 |
| Scientific Title | A monitoring study for predicting the efficacy of anti-PD-1/PD-L1 inhibitors using FDG-PET/CT and liquid biopsy |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2025/08/26 16:07:04 |
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Basic information
Public title
A monitoring study for predicting the efficacy of anti-PD-1/PD-L1 inhibitors using FDG-PET/CT and liquid biopsy
Acronym
A monitoring study for predicting the efficacy of anti-PD-1/PD-L1 inhibitors using FDG-PET/CT and liquid biopsy
Scientific Title
A monitoring study for predicting the efficacy of anti-PD-1/PD-L1 inhibitors using FDG-PET/CT and liquid biopsy
Scientific Title:Acronym
A monitoring study for predicting the efficacy of anti-PD-1/PD-L1 inhibitors using FDG-PET/CT and liquid biopsy
Region
| Japan |
Condition
Condition
Fifty patients aged 20 years or older with unresectable non-small cell lung cancer scheduled to receive anti-PD-1/PD-L1 inhibitors.
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A prospective study to evaluate the utility of FDG-PET/CT and blood-based liquid biopsy as regular monitoring methods for assessing treatment efficacy in anti-PD-1/PD-L1 antibody therapy for non-small cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FDG-PET/CT: Tumor SUVmax
Blood: Exosome-derived PD-L1 protein
Key secondary outcomes
FDG-PET/CT; Metabolic Tumor Volume (MTV), Total Lesion Glycolysis (TLG; SUV mean x MTV), and SUVmax in lymph nodes and metastatic lesions.
Blood; Exosome-derived GLUT1/4, number of blood-derived exosomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
After obtaining informed consent, FDG-PET/CT will be performed at three time points:
1: Before treatment,
2: One month after treatment initiation,
3: Four months after treatment initiation.
Blood sampling will be conducted before treatment and then monthly until four months after treatment initiation. The PET/CT at time point1 and in cases of recurrence will be covered by insurance, while the PET/CT scans at time points2 and 3 will be considered an intervention, as the radiopharmaceuticals for these scans will be provided by Nihon Medi-Physics Co., Ltd.
The following metabolic-related factors will be measured via PET/CT. The volume of blood drawn per sample in this study is 8 ml.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Non-small cell lung cancer cases in which FDG-PET/CT has been performed before treatment and the tumor proportion score (TPS) has been determined by PD-L1 immunohistochemical staining.
Key exclusion criteria
In cases where consent from the patient or their legal representative is not obtained.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Kawaguchi |
Organization
Tokyo Medical University
Division name
Department of Thoracic and Thyroid Surgery
Zip code
1600023
Address
6-7-1 Nishishinjuku, Shinjukuku, Tokyo
TEL
03-3342-6111
ykawaguchi219@gmail.com
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Kawaguchi |
Organization
Tokyo Medical University
Division name
Department of Thoracic and Thyroid Surgery
Zip code
1600023
Address
6-7-1 Nishishinjuku, Shinjukuku, Tokyo
TEL
03-3342-6111
Homepage URL
ykawaguchi219@gmail.com
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Nihon Medi-Physics Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo, Japan
Tel
03-3351-6141
ykawaguchi219@gmail.com
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 | 02 | Month | 20 | 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
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 17 | Day |
Last modified on
| 2025 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065209
