UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023462 |
|---|---|
| Receipt number | R000027035 |
| Scientific Title | Assessment of tumor response to immune checkpoint inhibitors using chest magnetic resonance imaging |
| Date of disclosure of the study information | 2016/08/03 |
| Last modified on | 2020/08/06 10:44:24 |
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Basic information
Public title
Assessment of tumor response to immune checkpoint inhibitors using chest magnetic resonance imaging
Acronym
Assessment of tumor response to immune checkpoint inhibitors using chest magnetic resonance imaging
Scientific Title
Assessment of tumor response to immune checkpoint inhibitors using chest magnetic resonance imaging
Scientific Title:Acronym
Assessment of tumor response to immune checkpoint inhibitors using chest magnetic resonance imaging
Region
| Japan |
Condition
Condition
advanced lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of chest MRI in evaluating tumor response to immune checkpoint therapy
Basic objectives2
Others
Basic objectives -Others
To compare the difference in tumor response between chest CT and MRI
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of tumor response 4 weeks after immune checkpoint therapy.
Key secondary outcomes
Evaluation of tumor response 2 and 8 weeks after immune checkpoint therapy.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving immune checkpoint therapy.
Pathologically diagnosed metastatic/relapse non-small-lung cancer.
Evaluable lesion >2cm.
ECOG PS 0-2.
Estimated prognosis > 3 months.
Age >18 years.
Informed consent given.
Key exclusion criteria
Autoimmune disease.
Interstitial lung disease.
Severe comorbidities.
Uncontrolled central nerve system lesion.
Severe renal disorder.
Inapplicable for MRI.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Devision, department of internal medicine
Zip code
4313192
Address
Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
TEL
0534352263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Karayama |
Organization
Hamamatsu Univ. School of Medicine
Division name
Department of clinical oncology
Zip code
4313192
Address
Handayama 1-20-1, Hamamatsu, Shizuoka pref. Japan
TEL
0534352419
Homepage URL
karayama@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Hamamatsu University School of Medicine Ethical Comittee
Address
Handayama 1-20-1 Hamamatsu
Tel
0534352111
rinri@hama-med.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 | 08 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate tumor response using chest MRI in addition to conventional chest CT.
Management information
Registered date
| 2016 | Year | 08 | Month | 03 | Day |
Last modified on
| 2020 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027035
