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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021847
Receipt No. R000025191
Scientific Title Treatment response of chemotherapy in patient with lung cancer:evaluation of tumor blood flow using H215O-PET/CT
Date of disclosure of the study information 2016/04/10
Last modified on 2018/10/11

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Basic information
Public title Treatment response of chemotherapy in patient with lung cancer:evaluation of tumor blood flow using H215O-PET/CT
Acronym evaluation of tumor blood flow using H215O-PET/CT
Scientific Title Treatment response of chemotherapy in patient with lung cancer:evaluation of tumor blood flow using H215O-PET/CT
Scientific Title:Acronym evaluation of tumor blood flow using H215O-PET/CT
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Pneumology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate tumor blood flow in patients with non small cell lung cancer (NSCLC) before and after treatment of Bevacizumab using 15O-water PET and to establish a method for treatment response.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes H215O-PET/CT is performed on the basis of the protocol which has been reported on Journal of Nuclear Medicine 2010;51:1684-1690.
H215O-PET/CT is performed before and about 1 to 3 days after chemotherapy.
Tumor perfusion (F)is calculated by using the following the standard single-tissue compartment model.
The therapy response using F value is compared with that using the therapy response using RECIST criteria.


Key secondary outcomes The time-dependent change in radioactivity concentration of tumor and in radioactivity concentration of radial artery are evaluated.
We investigate whether the artrial time-activity curve calculated from PET/CT can be substituted for the radioactivity concentration of radial artery or not.

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Radioactive water (370MBq) is injected intravenously before PET/CT.
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
80 years-old >
Gender Male and Female
Key inclusion criteria The patients who are planned to receive chemotherapy at our institution and agree to enter the present study.
Key exclusion criteria The Patients who do not agree to enter the present study and have problems with hemostatic function.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Hatazawa
Organization Osaka University Graduate School of Medicine
Division name Nuclear Medicine and Tracer Kinetics
Zip code
Address Yamadaoka 2-2, Suita-city
TEL 06-6879-3461
Email hatazawa@tracer.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Hatazawa
Organization Osaka University Graduate School of Medicine
Division name Nuclear Medicine and Tracer Kinetics
Zip code
Address Yamadaoka 2-2, Suita-city
TEL 06-6879-3461
Homepage URL
Email hatazawa@tracer.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
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
Address
Tel
Email

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 04 Month 10 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 Completed
Date of protocol fixation
2011 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 07 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
2016 Year 04 Month 09 Day
Last modified on
2018 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025191

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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