UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000029716 |
|---|---|
| Receipt number | R000033957 |
| Scientific Title | The usefulness of minimally invasive dynamic inspection technology (chest radiography) to prediction of perioperative pulmonary function after resection for lung cancer |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2022/10/29 12:42:47 |
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Basic information
Public title
The usefulness of minimally invasive dynamic inspection technology (chest radiography) to prediction of perioperative pulmonary function after resection for lung cancer
Acronym
The usefulness of minimally invasive dynamic inspection technology (chest radiography) to prediction of perioperative pulmonary function after resection for lung cancer
Scientific Title
The usefulness of minimally invasive dynamic inspection technology (chest radiography) to prediction of perioperative pulmonary function after resection for lung cancer
Scientific Title:Acronym
The usefulness of minimally invasive dynamic inspection technology (chest radiography) to prediction of perioperative pulmonary function after resection for lung cancer
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of software capable of evaluating dynamically functioning of respiration and circulation using
flat-panel detector (FDP)-based functional X-ray imaging, and evaluation of more physiological pulmonary function after resection for lung cancer using this software.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pre- and postoperative
1) Dynamic X-ray imaging
2) Ventilation/perfusion mapping images
3) Diaphragm excursion
4) Difference of chest expansion
5) Predicted postoperative pulmonary function
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Examination of flat-panel detector (FDP)-based functional X-ray imaging in the perioperative period
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
1) Patient who has confirmed diagnosis of primary lung cancer or is strongly suspected, has surgical indication for radical resection, scheduled to be operated or performed.
2) Forced breathing, deep breathing, breath holding are possible in standing or supine position.
3) Informed consent for clinical trial (document).
Key exclusion criteria
1) women in pregnancy
2) Patients judged for inappropriation by attending physician or lead principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Hanaoka |
Organization
Shiga University of Medical Science
Division name
General Thoracic Surgery
Zip code
5202192
Address
Seta-Tsukinowa, Otsu, Shiga, Japan
TEL
+81-077-548-2244
hanaoka@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Hanaoka |
Organization
Shiga University of Medical Science
Division name
General Thoracic Surgery
Zip code
5202192
Address
Seta-Tsukinowa, Otsu, Shiga, Japan
TEL
+81-077-548-2244
Homepage URL
hanaoka@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Konica Minolta
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SUMS research ethics committee
Address
Seta-Tsukinowa, Otsu, Shiga, Japan
Tel
0775483576
hqrec@belle.shiga-med.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
滋賀医科大学附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
Main results already published
Date of protocol fixation
| 2017 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 25 | Day |
Last modified on
| 2022 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033957
