UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048041 |
|---|---|
| Receipt number | R000054760 |
| Scientific Title | Usefulness of Bladder Volume Real-Time Monitoring System in Pelvic Image-Induced Radiation Therapy |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2025/04/14 15:34:17 |
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Basic information
Public title
Usefulness of Bladder Volume Real-Time Monitoring System in Pelvic Image-Induced Radiation Therapy
Acronym
Dfree
Scientific Title
Usefulness of Bladder Volume Real-Time Monitoring System in Pelvic Image-Induced Radiation Therapy
Scientific Title:Acronym
Dfree
Region
| Japan |
Condition
Condition
Patients receiving radiation therapy under bladder volume control
Classification by specialty
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improving the efficiency of high-precision radiation therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Volume difference between treatment plan CT and kVCT bladder volume at the time of treatment
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Since the bladder dose volume, urinary intention awareness intensity, residual urine increase rate, etc. differ for each case, all trials of the D method, the on-time standby method, and the self-report method are all performed and assigned in the same case. In the case of intensity-modulated radiation therapy for prostate cancer of one person, where 35 ~ 40 treatments are required, the D method (2 times), the regular waiting method (2 times), and the self-report method (1 time) are performed each week on the day of radiation therapy 5 times a week.
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 receiving radiation therapy under bladder volume control
2 Patients who can measure by Dfree
3 Patients with possible urinary abstinence and self-urination
Key exclusion criteria
1 Patients with anuria and oliguria.
2 Patients who have difficulty communicating with the patient
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Ohno |
Organization
Kamagaya General Hospital
Division name
Radiation therapy
Zip code
273-0121
Address
929-6 Hatsutomi, Kamagaya-City Chiba
TEL
047-498-8111
chiken@kamagaya-hp.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Ohno |
Organization
Kamagaya General Hospital
Division name
Radiation therapy
Zip code
273-0121
Address
929-6 Hatsutomi, Kamagaya-City Chiba
TEL
047-498-8111
Homepage URL
chiken@kamagaya-hp.jp
Sponsor or person
Institute
Kamagaya General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kamagaya General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The TOKUSHUKAI GROUP ETHICS COMMITTEE
Address
1-3-1 Koji-machi, Chiyoda-ku, Tokyo
Tel
03-3263-4801
mirai-ec4@mirai-iryo.com
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
| 2022 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
M/A
Number of participants that the trial has enrolled
11
Results
There were no statistically significant differences in bladder volume between the planning CT and treatment-time kVCT across the experimental group and the two control groups.
Results date posted
| 2025 | Year | 04 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study cohort comprised 11 patients (10 males and 1 female), including five cases of post-operative prostate cancer, five cases of definitive radiotherapy for prostate cancer, and one case of rectal cancer.
Participant flow
Only patients who provided informed consent after receiving an explanation of the study were included.
Adverse events
N/A
Outcome measures
Difference in bladder volume between the planning CT and the kVCT acquired at the time of treatment
Plan to share IPD
N/A
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 13 | 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
Management information
Registered date
| 2022 | Year | 06 | Month | 13 | Day |
Last modified on
| 2025 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054760
