UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019672 |
|---|---|
| Receipt number | R000022730 |
| Scientific Title | Quantitative measurement of pulmonary tumor blood flow and evaluation of chemotherapy response using dual input perfusion CT |
| Date of disclosure of the study information | 2015/11/09 |
| Last modified on | 2019/05/13 20:29:39 |
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Basic information
Public title
Quantitative measurement of pulmonary tumor blood flow and evaluation of chemotherapy response using dual input perfusion CT
Acronym
Evaluation of chemotherapy response using dual input perfusion CT
Scientific Title
Quantitative measurement of pulmonary tumor blood flow and evaluation of chemotherapy response using dual input perfusion CT
Scientific Title:Acronym
Evaluation of chemotherapy response using dual input perfusion CT
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of dual input perfusion CT for evaluation of lung cancer chemotherapy by comparing tumor blood flow before and after chemotherapy.
Basic objectives2
Others
Basic objectives -Others
To assess the feasibility of measurement of tumor blood flow by dual input perfusion CT
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pulmonary artery flow and bronchial artery flow measured by dual input perfusion CT performed before, 1-3 days after, and 1 month after first chemotherapy.
Key secondary outcomes
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The lesion is diagnosed as lung cancer from clinical information, pathological findings, or image findings; the patient will have chemotherapy; the diameter of the lesion is more than 15 mm; the patient has normal renal function (eGFR > 60/ml/min/1.73m2).
Key exclusion criteria
There was contraindication to administration of contrast medium; unable to provide informed consent.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Yanagawa |
Organization
Osaka University Graduate School of Medicine
Division name
Diagnostic and Interventional Radiology
Zip code
565-0871
Address
2-2 Yamadaoka,Suita,Osaka
TEL
06-6879-3434
m-yanagawa@radiol.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Hata |
Organization
Osaka University Graduate School of Medicine
Division name
Diagnostic and Interventional Radiology
Zip code
565-0871
Address
2-2 Yamadaoka,Suita,Osaka
TEL
06-6879-3434
Homepage URL
a-hata@radiol.med.osaka-u.ac.jp
Sponsor or person
Institute
Diagnostic and Interventional Radiology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Medical Innovation Osaka University Hospital
Address
Innovation Center, 2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 09 | 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
3
Results
Included patinets underwent Dual input perfusion CT, and we could predict the pulmonary flow and the bronchial flow. However, we stopped
this research, because we could not include enough number of patinets.
Results date posted
| 2019 | Year | 05 | Month | 13 | Day |
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
Terminated
Date of protocol fixation
| 2015 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We recruit patients who are confirmed to meet the criteria by respiratory medicine doctors.
Recruitment period is from Nov. 9, 2015 to Dec. 31, 2020.
Included patinets underwent Dual input perfusion CT, and we could predict the pulmonary flow and the bronchial flow. However, we stopped
this research, because we could not include enough number of patinets.
Management information
Registered date
| 2015 | Year | 11 | Month | 06 | Day |
Last modified on
| 2019 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022730
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
