UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole
Acronym	Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole
Scientific Title	Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole
Scientific Title:Acronym	Evaluation of tumor hypoxia for stereotactic radiotherapy using F-18 fluoromisonidazole
Region	Japan

Condition
Condition	Lung cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the change of tumor hypoxia in lung cancer using 18F-fluoromisonidazole after stereotactic radiotherapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of 18F-MISO uptake between before and after treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	To perform F-MISO PET/CT before and 1 day after treatment
Interventions/Control_2	To perform F-MISO PET/CT before and 2 day after treatment
Interventions/Control_3	To perform F-MISO PET/CT before and 3 day after treatment
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	85 years-old >
Gender	Male and Female
Key inclusion criteria	1)Adaptable of stereotactic radiotherapy for primary or metastatic lung malignant tumor less of equal 5cm. Fulfilling both of the following conditions and clinically diagnosed as NSCLC. a) increase in tumor size of 1 mm or more, or consolidation/tumor ratio turning >50% from <=50% on CT scans performed 28 days or more apart. b) positive accumulation on FDG-PET. 2)Performance status (ECOG): 0-2 3)Enable for performing PET/CT 4)Aged 20 to 84 5)signed informed consent
Key exclusion criteria	1)During the pregnancy or a pregnant female patient we are possible or are nursing. 2)The patient whom we merge psychosis or neurological manifestation, and it is judged to have difficulty with participation to an examination. 3)Severe complications whom enable to perform PET/CT 4)Other reasons with inadequate to enroll this trial
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Yasumasa Middle name Last name Nishimura
Organization	Kindai University
Division name	Department of Radiation Oncology,
Zip code	5898511
Address	377-2,ohnohigashi,osakasayamashi,osaka
TEL	072-366-0221
Email	im022012@med.kindai.ac.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Inada
Organization	Kindai University
Division name	Department of Radiation Oncology,
Zip code	5898511
Address	377-2,ohnohigashi,osakasayamashi,osaka
TEL	072-366-0221
Homepage URL
Email	im022012@med.kindai.ac.jp

Sponsor
Institute	Kindai University
Institute
Department

Funding Source
Organization	Kindai University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kindai Univarsity Faclty of medicine
Address	Ohnohigashi 377-2, Osakasayama city, Osaka
Tel	0723880221
Email	im022012@med.kindai.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	2017 Year 07 Month 24 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	Enrolling by invitation
Date of protocol fixation	2017 Year 03 Month 08 Day
Date of IRB	2016 Year 11 Month 08 Day
Anticipated trial start date	2017 Year 03 Month 08 Day
Last follow-up date	2023 Year 03 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 07 Month 22 Day
Last modified on	2019 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032427

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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