UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031095 |
|---|---|
| Receipt number | R000035501 |
| Scientific Title | Usefulness of FDG-PET/CT examination as prediction of effect of immune checkpoint inhibitors in patients with non-small cell lung cancer : a pilot study |
| Date of disclosure of the study information | 2018/02/02 |
| Last modified on | 2019/02/18 16:11:30 |
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Basic information
Public title
Usefulness of FDG-PET/CT examination as prediction of effect of immune checkpoint inhibitors in patients with non-small cell lung cancer : a pilot study
Acronym
Usefulness of FDG-PET/CT as prediction of effect of immune checkpoint inhibitors in lung cancer
Scientific Title
Usefulness of FDG-PET/CT examination as prediction of effect of immune checkpoint inhibitors in patients with non-small cell lung cancer : a pilot study
Scientific Title:Acronym
Usefulness of FDG-PET/CT as prediction of effect of immune checkpoint inhibitors in lung cancer
Region
| Japan |
Condition
Condition
advanced and recurrent non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the clinical usefulness of the response evaluation after immune checkpoint inhibitors of FDG-PET/CT and thallium scintigraphy and conventional CT.
Basic objectives2
Others
Basic objectives -Others
To evaluate diagnostic relevancy of FDG-PET/CT imaging
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate correlation between response rates of immune checkpoint inhibitors by PERCIST, by thallium scintigraphy and by RECIST before and 8 weeks after treatment.
Key secondary outcomes
To evaluate correlation between response rates of immune checkpoint inhibitors by PERCIST, by thallium scintigraphy and progression free survival and overall survival.
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
| Medicine |
Interventions/Control_1
All patients undergo FDG-PET/CT and thallium scintigraphy before and 8 weeks after initiation of immune checkpoint inhibitors 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)Aged 20<=
2)Histologically or cytologically proven non-small cell lung cancer
3)Stage IIIB without any indications for radiotherapy or stage IV
ECOG PS 0 or 1
4)Written informed consent
Key exclusion criteria
1)Patients with serious liver dysfunction or renal dysfunction
2)Pregnant or lactating females
3)Patients with clinically significant psychiatric disease that would interfere with participation in this study
4)Patients with history of previous immune checkpoint inhibitor treatment
5)Patients with history of autoimmune diseases
6)Patients with serious interstitial lung disease or infection
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keita Utsunomiya |
Organization
Kansai Medical University
Division name
Department of Radiology
Zip code
Address
10-15, Fumizono-cho, Moriguchi city, Osaka, Japan
TEL
06-6992-1001
keitaut@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayasu Kurata |
Organization
Kansai Medecal University Hospital
Division name
Department of Thoracic Oncology
Zip code
Address
2-3-1, Shinma-chi, Hirakata city, Osaka, Japan
TEL
072-804-0101
Homepage URL
kuratat@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Nihon Medi-Physics Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
関西医科大学附属病院（大阪府）
関西医科大学総合医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 01 | Day |
Last modified on
| 2019 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035501
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/12/25 | PET Tl治験解析データ .xlsx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
