UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052173 |
|---|---|
| Receipt number | R000059537 |
| Scientific Title | Optimization of the respiration phase regarding the effects of respiratory motion on LET distribution in abdominal and pelvic carbon radiation therapy |
| Date of disclosure of the study information | 2023/09/11 |
| Last modified on | 2023/09/11 16:08:20 |
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Basic information
Public title
Optimization of the respiration phase regarding the effects of respiratory motion on LET distribution in abdominal and pelvic carbon radiation therapy
Acronym
Respiratory motion in abdominal and pelvic carbon ion radiation therapy
Scientific Title
Optimization of the respiration phase regarding the effects of respiratory motion on LET distribution in abdominal and pelvic carbon radiation therapy
Scientific Title:Acronym
Respiratory motion in abdominal and pelvic carbon ion radiation therapy
Region
| Japan |
Condition
Condition
abdominal and pelvic sarcoma
Classification by specialty
| Orthopedics | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between respiratory phase and movement distance for abdominopelvic sarcoma and examine conditions that can ensure the robustness (stable reproducibility) of the dose distribution and LET distribution created by IMPT (intensity modulated particle therapy).
Basic objectives2
Others
Basic objectives -Others
Comparing the difference in the movement distance between respiratory-gated CT and 4DCT
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To calculate the dose distribution and LET distribution in the phase used for irradiation and evaluate the influence of respiratory movement on DVHs and LET distributions of tumors, and organs at risk.
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
4DCT imaging
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients scheduled to undergo carbon ion radiotherapy for abdominopelvic tumors within the registration period (from the date of research approval until March 31, 2025).
2) Persons who wish to participate in the research based on their own will and who are judged by the researcher's doctor to be able to understand the informed consent document.
3) If the research subject is a minor, consent can be obtained from a representative.
Key exclusion criteria
1) Those whose heavy ion radiotherapy was discontinued for some reason after consent was obtained.
2) Persons in whom an unexpected abnormality was found in a test conducted after consent was obtained.
3) Persons who have difficulty performing the two types of CT scans due to cognitive impairment.
4) Persons with metal implants that affect treatment planning CT.
5) Other persons who are judged to be ineligible as research subjects by a doctor who is a researcher, etc.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Imai |
Organization
National Institute of Quantum Science and Technology
Division name
QST Hospital
Zip code
2630024
Address
4-9-1 Anagawa Inage Chiba
TEL
0432063306
imai.reiko@qst.go.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Imai |
Organization
National Institute of Quantum Science and Technology
Division name
QST Hospital
Zip code
2630024
Address
4-9-1 Anagawa, Inage, Chiba
TEL
0432063306
Homepage URL
imai.reiko@qst.go.jp
Sponsor or person
Institute
National Institute of Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institute of Quantum Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes for Quantum Science and Technology
Address
4-9-1 Anagawa, Inage, Chiba
Tel
0432063306
imai.reiko@qst.go.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 11 | 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 | 16 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 11 | Day |
Last modified on
| 2023 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059537
