UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007992 |
|---|---|
| Receipt number | R000009406 |
| Scientific Title | Influence of Radiofrequency Ablation of Lung Cancer on Blood Perfusion in the Peripheral Lung Tissue and Lung Tumor: Evaluation with Dual Energy CT |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2017/11/24 10:05:15 |
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Basic information
Public title
Influence of Radiofrequency Ablation of Lung Cancer on Blood Perfusion in the Peripheral Lung Tissue and Lung Tumor: Evaluation with Dual Energy CT
Acronym
Influence of Radiofrequency Ablation of Lung Cancer on Blood Perfusion in the Peripheral Lung Tissue and Lung Tumor: Evaluation with Dual Energy CT
Scientific Title
Influence of Radiofrequency Ablation of Lung Cancer on Blood Perfusion in the Peripheral Lung Tissue and Lung Tumor: Evaluation with Dual Energy CT
Scientific Title:Acronym
Influence of Radiofrequency Ablation of Lung Cancer on Blood Perfusion in the Peripheral Lung Tissue and Lung Tumor: Evaluation with Dual Energy CT
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate blood flow of the lung parenchyma and lung tumor after radiofrequency ablation with Dual Energy CT
Basic objectives2
Others
Basic objectives -Others
Influence of radiofrequency ablation og lung cancer on blood perfusion in the peripheral lung tissue and lung tumor
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To determine the incidence of decrease in blood perfusion in the peripheral lung tissue after radiofrequency ablation of lung cancer
Key secondary outcomes
To determine the incidence of decrease in blood perfusion in the peripheral lung tumor after radiofrequency ablation of lung cancer
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
When blood perfusion in the peripheral lung parenchyma decreases, pulmonary perfusion scintigraphy is performed to confirm the finding.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who undergo RFA of lung tumor and provide informed consent for this study
Key exclusion criteria
The patients with allergy to iodined constrast media
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanazawa Susumu |
Organization
Okayama university Graduate school of Medicine, Dentistry and Pharmaceutical
Division name
Department of Radiology
Zip code
Address
2-5-1 Shikata-cho Kita-ku Okayama
TEL
086-235-7313
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomita Koji |
Organization
Okayama University Hospital
Division name
Department of Radiology
Zip code
Address
2-5-1 Shikata-cho Kita-ku Okayama
TEL
086-235-7313
Homepage URL
Sponsor or person
Institute
Okayama university Graduate school of Medicine, Dentistry and Pharmaceutical Department of Radiology
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | 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
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
| 2012 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 20 | Day |
Last modified on
| 2017 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009406
