UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021847 |
|---|---|
| Receipt number | 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 12:59:21 |
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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
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
hatazawa@tracer.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025191
