UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052404 |
|---|---|
| Receipt number | R000059823 |
| Scientific Title | Changes in lymphoid tissue proliferation with PD-1 inhibitor therapy for lung cancer using FLT-PET/MRI; a retrospective study |
| Date of disclosure of the study information | 2023/10/04 |
| Last modified on | 2025/07/04 19:33:29 |
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Basic information
Public title
Changes in lymphoid tissue proliferation with PD-1 inhibitor therapy for lung cancer using FLT-PET/MRI; a retrospective study
Acronym
Changes in lymphoid tissue proliferation with PD-1 inhibitor therapy for lung cancer using FLT-PET/MRI; a retrospective study
Scientific Title
Changes in lymphoid tissue proliferation with PD-1 inhibitor therapy for lung cancer using FLT-PET/MRI; a retrospective study
Scientific Title:Acronym
Changes in lymphoid tissue proliferation with PD-1 inhibitor therapy for lung cancer using FLT-PET/MRI; a retrospective study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine the relationship between the therapeutic effect of PD-1 antibody therapy and changes in the proliferation of lymphoid tissues such as spleen and bone marrow, measured using FLT accumulation, after PD-1 antibody therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage change in FLT accumulation in lymphoid tissues (spleen and bone marrow) before and after PD-1 inhibitor treatment and tumor response to PD-1 inhibitor treatment
Key secondary outcomes
Relationship between FLT accumulation and patient background (gender, age, height, weight, BMI, smoking history, comorbidities, previous treatment), blood test data and its rate of change (white blood cell count, neutrophil count, lymphocyte count, red blood cell count, hemoglobin, platelet count, RDW, CRP, T.bil, AST, ALT, LDH, BUN, Cr, albumin, tumor markers).
Percentage change in FLT accumulation in lymphoid tissue before and after PD-1 inhibitor treatment and its association with progression-free survival and overall survival for PD-1 antibody treatment.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age 20 or over.
2) Patients with pathologically confirmed advanced non-small cell lung cancer (NSCLC), and indication of PD-1 immune checkpoint inhibitors (nivolumab or pembrolizumab).
3) Written informed consent.
Key exclusion criteria
1) Patients with metallic device in their body.
2) Patients with claustrophobia.
3) Pregnant or lactating woman.
4) Other cases attending physician it is determined unsuitable for registration of the study.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Third Department of Internal Medicine
Zip code
9101193
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui
TEL
+81776613111
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
Third Department of Internal Medicine
Zip code
9101193
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Fukui
TEL
+81776613111
Homepage URL
umeda@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Yukihiro Umeda
Funding Source
Organization
MEXT KAKENHI (JP22K07688)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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-cho, Fukui
Tel
+81776613111
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
| 2023 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
https://ejnmmires.springeropen.com/articles/10.1186/s13550-025-01225-7
Publication of results
Published
Result
URL related to results and publications
https://ejnmmires.springeropen.com/articles/10.1186/s13550-025-01225-7
Number of participants that the trial has enrolled
25
Results
In patients with advanced NSCLC who achieved a tumor response, proliferation decreased in the bone marrow, but not in the spleen or lymph nodes, 6 weeks after treatment initiation. 18F-FLT PET can help monitor changes in tumor immunity in each lymphoid tissue and may serve as a biomarker for the response to immune checkpoint inhibitor therapy.
Results date posted
| 2025 | Year | 07 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Anti-programmed cell death-1 (anti-PD-1) therapy has become the standard immunotherapy for patients with advanced non-small cell lung cancer (NSCLC). However, little is known about the organs influenced by PD-1 inhibitors on a patient tumor immunity. We examined the changes in lymphoid tissue proliferation before and after PD-1 inhibitor treatment using 18F-fluorothymidine (18F-FLT) positron emission tomography (PET).
Participant flow
This was a retrospective study involving patients who participed in a prospective trial using 18F-FLT PET to evaluate the efficacy of PD-1 inhibitors in advanced NSCLC between June 2017 and July 2019 at the University of Fukui Hospital. This study was reviewed and approved by The Research Ethics Committee of the University of Fukui.
Adverse events
Not applicable
Outcome measures
The baseline 18F-FLT accumulation in the lymphoid tissues or blood test data between the progressive disease (PD) and non-PD groups were not significantly different. In the spleen and lymph nodes, changes in 18F-FLT accumulation from baseline to 2 or 6 weeks did not differ between the non-PD and PD groups. However, mediastinal lymph node accumulation tended to increase transiently at week 2 compared to that before treatment initiation (median SUVmax 2.19 vs. 2.64, P = 0.073). Regarding changes in vertebral accumulation in the non-PD group, the SUVmax, and PVV were significantly lower at weeks 2 and 6. In the percent changes in 18F-FLT accumulation of the vertebrae after the treatment initiation, the PD group was significantly higher than the non-PD group at the 6-week evaluation (median deltaTVP0-6, 17.0% vs. -13.0%, P = 0.0080).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation Items
Patient background: patient initials, gender, age, height, weight, BMI, smoking history, comorbidities, medication history, medical history, current medical history, previous treatment
FLT-PET/MRI imaging data: FLT accumulation in regional lymph nodes, spleen, vertebrae, and pelvis
Blood test data: white blood cell count, neutrophil count, lymphocyte count, red blood cell count, hemoglobin, platelet count, RDW, CRP, T.bil, AST, ALT, LDH, BUN, Cr, albumin, tumor markers (CEA, SLX, SCC, CYFRA)
PD-1 inhibitor treatment status: type of PD-1 inhibitor therapy, treatment initiation date, and the number of doses administered
Effectiveness of anti-tumor therapy with PD-1 inhibitor therapy by RECIST and irRECIST (best overall response, progression-free survival, and overall survival)
Confirmation of adverse events of PD-1 inhibitor therapy using CTCAE
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2025 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059823
