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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027460
Receipt No. 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 2020/06/03

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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
Email 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
Email umeda@u-fukui.ac.jp

Sponsor
Institute Third department of internal medicine, Universtiy of Fukui
Institute
Department

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
Email 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
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 No longer recruiting
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
2020 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031460

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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