UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027460 |
|---|---|
| Receipt number | R000031460 |
| Scientific Title | FLT-PET/MRI imaging for the evaluation of early response to immune checkpoint inhibitors |
| Date of disclosure of the study information | 2017/05/25 |
| Last modified on | 2022/01/24 13:03:34 |
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Basic information
Public title
FLT-PET/MRI imaging for the evaluation of early response to immune checkpoint inhibitors
Acronym
FLT-PET/MRI imaging for the evaluation of early response to immune checkpoint inhibitors
Scientific Title
FLT-PET/MRI imaging for the evaluation of early response to immune checkpoint inhibitors
Scientific Title:Acronym
FLT-PET/MRI imaging for the evaluation of early response to immune checkpoint inhibitors
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
Programmed death 1 (PD-1) immune checkpoint inhibitor antibodies were active and durable in some patients with advanced non-small cell lung cancer. However, it is difficult to evaluate early response with conventional imaging (i.e. computed tomography).
The aim of this study is to clarify whether serial change of FLT-PET/MRI findings can predict long term tumor response of PD-1 immune checkpoint inhibitor antibody.
Basic objectives2
Others
Basic objectives -Others
To evaluate diagnostic relevancy of FLT-PET/MRI imaging.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between serial FLT-PET/MRI findings of the tumor and progression free survival and tumor response.
Key secondary outcomes
1. Association of serial change of FLT-PET/MRI findings with overall survival.
2. Association of FLT-PET/MRI findings and PD-L1 expression of lung cancer.
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
| Device,equipment |
Interventions/Control_1
All patients undergo FLT-PET/MRI before and 2 and 6 weeks after initiation of PD-1 immune checkpoint inhibitors.
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) Pathologically confirmed advanced non-small cell lung cancer (NSCLC)
2) Indication of PD-1 immune checkpoint inhibitors (Nivolumab or Pembrolizumab)
3) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
4) Patient with evaluable lesion based on RECIST
5) Written informed consent
Key exclusion criteria
1) Pregnant woman
2) Patients with metalic device in their body
3) Patients with claustrophobia
4) Patients with obvious interstitial pneumonia or pulmonary fibrosis in the chest X-ray.
5) Patients with collagen vascular disease or autoimmune diseases
6) 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
University of Fukui
Division name
Third department of internal medicine
Zip code
9101193
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL
0776-61-3111
umeda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yukihiro |
| Middle name | |
| Last name | Umeda |
Organization
University of Fukui
Division name
Third department of internal medicine
Zip code
9101193
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL
0776-61-3111
Homepage URL
umeda@u-fukui.ac.jp
Sponsor or person
Institute
Third department of internal medicine, Universtiy of Fukui
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
The Research Ethics Committee of University of Fukui
Address
23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
Tel
0776-61-3111
chiken@ml.cii.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
| 2017 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
https://jitc.bmj.com/content/9/7/e003079.long
Publication of results
Published
Result
URL related to results and publications
https://jitc.bmj.com/content/9/7/e003079.long
Number of participants that the trial has enrolled
26
Results
This prospective study showed that changes in TLP measured by 18F-FLT PET as early as 2 weeks after treatment initiation could have utility as predictors of the response and progression-free survival of NSCLC patients treated with anti-PD-1 antibody therapy.
Results date posted
| 2022 | Year | 01 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age was 70.4 years (range 54 to 82). Histology of the patients was as follows, 11 (44%) with squamous cell carcinoma,9 (36%) with adenocarcinoma, 3 (12%) with NSCLC not otherwise specified, 1 (4%) with large cell carcinoma, and 1 (4%) with pleomorphic carcinoma.
Participant flow
Consecutive 26 patients with advanced NSCLC were prospectively enrolled in this study. Of these, 1 patient did not undergo 2-week 18F-FLT PET/MRI because of discontinuance of pembrolizumab treatment due to drug induced pneumonia, and 3 did not undergo 6-week 18F-FLT PET/MRI because of early disease progression. Therefore, 25 patients were analyzed baseline and 2-week 18F-FLT PET, and 22 patients were analyzed baseline and 6-week 18F-FLT PET.
Adverse events
Any adverse events by 18F-FLT PET/MRI were not observed.
Outcome measures
This prospective study showed that changes in TLP measured by 18F-FLT PET as early as 2 weeks after treatment initiation could have utility as predictors of the response and progression-free survival of NSCLC patients treated with anti-PD-1 antibody therapy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 01 | 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
| 2017 | Year | 05 | Month | 23 | Day |
Last modified on
| 2022 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031460
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