UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000020707
Receipt No. R000023415
Scientific Title FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer
Date of disclosure of the study information 2016/01/23
Last modified on 2020/06/03 (Ver. 6)

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Basic information
Public title FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer
Acronym FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer
Scientific Title FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer
Scientific Title:Acronym FDG-PET/MRI imaging for the evaluation of early response to nivolumab in patients with previously treated non-small cell lung cancer
Region
Japan

Condition
Condition Previously treated non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Nivolumab, a programmed death 1 immune checkpoint inhibitor antibody, was 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 FDG-PET/MRI findings can predict long term tumor response of nivolumab monotherapy.
Basic objectives2 Others
Basic objectives -Others To evaluate diagnostic relevancy of FDG-PET/MRI imaging.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Relationship between serial FDG-PET/MRI findings and progression free survival and tumor response.
Key secondary outcomes 1. Association of serial change of FDG-PET/MRI findings with overall survival.
2. To evaluate the FDG-PET/MRI findings of side effect of nivolumab therapy.
3. Association of FDG-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 FDG-PET/MRI before and 2, 8 and 16 weeks after initiation of nivolumab therapy.
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), and one or more prior systemic treatment regimens for advanced NSCLC
2) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
3) Patient with evaluable lesion based on RECIST
4) Written informed consent
Key exclusion criteria 1) Fasting serum glucose levels above 150 mg/dl
2) Pregnant woman
3) Patients with metalic device in their body
4) Patients with claustrophobia
5) Patients with obvious interstitial pneumonia or pulmonary fibrosis in the chest X-ray.
6) Patients with collagen vascular disease or autoimmune diseases
7) 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
2016 Year 01 Month 23 Day

Related information
URL releasing protocol https://jitc.bmj.com/content/8/1/e000349
Publication of results Unpublished

Result
URL related to results and publications https://jitc.bmj.com/content/8/1/e000349
Number of participants that the trial has enrolled 25
Results 
Patients with non-progressive disease (non-PD) had significantly decreased TLG, increased ADCmean (that is, negative dADCmean), and lower dTLG+dADCmean than patients with PD. Among the parameters tested, receiver operating characteristic curve analysis revealed that a cut-off value of 16.5 for dTLG+dADCmean had the highest accuracy (92%) for distinguishing between non-PD and PD patients.
Results date posted
2020 Year 06 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Twenty-five patients with previously treated NSCLC were enrolled prospectively and underwent 18F-FDG PET/MRI before and at 2 weeks after nivolumab therapy.
Participant flow 
We prospectively enrolled 25 consecutive patients treated at the University of Fukui Hospital from January 2016 to February 2018, and the protocol-defined final analysis was performed on August 31, 2018.
Adverse events 
None
Outcome measures 
A cut-off value of 16.5 for dTLG+dADCmean had the highest accuracy (92%) for distinguishing between non-PD and PD patients
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 01 Month 18 Day
Date of IRB
2016 Year 01 Month 22 Day
Anticipated trial start date
2016 Year 01 Month 23 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 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=R000023415