UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020707 |
|---|---|
| Receipt number | 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 11:01:21 |
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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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023415
