UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031009 |
|---|---|
| Receipt number | R000035402 |
| Scientific Title | Usefulness of FDG-PET/CT to predict the response after anti-PD-1 antibody in patients with previously treated advanced non-small cell lung cancer: a multi-institutional study |
| Date of disclosure of the study information | 2018/01/27 |
| Last modified on | 2018/01/26 00:24:51 |
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Basic information
Public title
Usefulness of FDG-PET/CT to predict the response after anti-PD-1 antibody in patients with previously treated advanced non-small cell lung cancer: a multi-institutional study
Acronym
FDG-PET/CT and prediction of anti-PD-1 antibody in lung cancer
Scientific Title
Usefulness of FDG-PET/CT to predict the response after anti-PD-1 antibody in patients with previously treated advanced non-small cell lung cancer: a multi-institutional study
Scientific Title:Acronym
FDG-PET/CT and prediction of anti-PD-1 antibody in lung cancer
Region
| Japan |
Condition
Condition
Previously treated advanced non-small cell lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Nivolumab or Pembrolizumab, a programmed death 1 immune checkpoint inhibitor antibody, was effective for patients with previously treated advanced NSCLC. However, the presence of promising biomarker still remains unclear. Little is known about the role of CT scan as an appropriate radiological modality. Therefore, we conducted the clinical study to evaluate FDG-PET as a predictor of nivolumab.
Basic objectives2
Others
Basic objectives -Others
To monitor the outcome after treatment
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changeing of SUVmax, MTV and TLG, and the efficacy of anti-PD-1 antibody such as nivolumab or pembrolizumab.
Evaluation after 4weeks and 9weeks from administration of anti-PD-1 antibody.
Key secondary outcomes
Overall survival and progression-free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
All patients undergo FDG-PET/MRI before and 4 weeks and 9weeks after initiation of anti-PD-1 antibody 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) Pregnant woman
2) Patients with obvious interstitial pneumonia or pulmonary fibrosis in the chest X-ray.
3) Patients with collagen vascular disease or autoimmune diseases
4) Other cases attending physician it is determined unsuitable for registration of the study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyochi Kaira |
Organization
Gunma Univetsity Hospital
Division name
Inovative medical research center
Zip code
Address
3-39-15, showa-machi, Mebashi, Gunma
TEL
027-220-8147
kkaira1970@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyochi Kaira |
Organization
Gunma Univetsity Hospital
Division name
Inovative medical research center
Zip code
Address
3-39-15, showa-machi, Mebashi, Gunma
TEL
027-220-8147
Homepage URL
kkaira1970@yahoo.co.jp
Sponsor or person
Institute
Gunma 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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | 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 | 01 | Month | 26 | Day |
Last modified on
| 2018 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035402
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
