UMIN-CTR Clinical Trial

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
Email	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
Email	karayama@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027035