UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054062 |
|---|---|
| Receipt number | R000061723 |
| Scientific Title | Quantification of radiation pneumonitis and Prediction of Respiratory Function Changes Using 4D-CT and Respiratory Function Testing |
| Date of disclosure of the study information | 2024/04/04 |
| Last modified on | 2024/04/04 15:50:55 |
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Basic information
Public title
Quantification of radiation pneumonitis and Prediction of Respiratory Function Changes Using 4D-CT and Respiratory Function Testing
Acronym
Quantification of radiation pneumonitis and Prediction of Respiratory Function Changes Using 4D-CT and Respiratory Function Testing
Scientific Title
Quantification of radiation pneumonitis and Prediction of Respiratory Function Changes Using 4D-CT and Respiratory Function Testing
Scientific Title:Acronym
Quantification of radiation pneumonitis and Prediction of Respiratory Function Changes Using 4D-CT and Respiratory Function Testing
Region
| Japan |
Condition
Condition
malignant thoracic tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
1) Quantify radiation pneumonitis using the rate of change obtained from respiratory function test data before and after radiotherapy.
2) To predict post-treatment respiratory function changes in radiotherapy patients by analyzing pre- and post-treatment respiratory function changes, lung function images obtained from 4D-CT, and pulmonary DVH parameters.
Basic objectives2
Others
Basic objectives -Others
1) Quantify radiation pneumonitis using the rate of change obtained from respiratory function test data before and after radiotherapy.
2) To predict post-treatment respiratory function changes in radiotherapy patients by analyzing pre- and post-treatment respiratory function changes, lung function images obtained from 4D-CT, and pulmonary DVH parameters.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Quantification of radiation pneumonitis
2) Prediction of post-treatment respiratory function changes in radiotherapy patients
Key secondary outcomes
1) Prediction of radiation pneumonitis range
2) Correlation between pulmonary function images obtained from 4D-CT images and respiratory function tests
3) Influence of drugs used in combination with radiotherapy on respiratory function
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients must be at least 20 years of age and have histologically proven malignancy.
2) Patients with no previous radiation therapy to the chest.
3) Patients who are scheduled to undergo radical radiotherapy for lung cancer with a total dose of 40 Gy or more.
Key exclusion criteria
1) Patients with active interstitial pneumonia requiring treatment.
2) Patients with serious complications (liver cirrhosis, diabetes, cardiac disease, etc.).
3) Pregnant and lactating women.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Itonaga |
Organization
Tokyo Medical University
Division name
Department of Radiology
Zip code
160-0023
Address
6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
itonaga@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Itonaga |
Organization
Tokyo Medical University
Division name
Department of Radiology
Zip code
160-0023
Address
6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
itonaga@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of Tokyo Medical University
Address
6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
Sys_IRB@tokyo-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
東京医科大学病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
IRB number:T2023-0095
Management information
Registered date
| 2024 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061723
