UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059242 |
|---|---|
| Receipt number | R000066795 |
| Scientific Title | Investigating radiotherapy effects on changes in bone marrow using photon-counting computed tomography |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/10/01 10:44:42 |
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Basic information
Public title
Investigating changes in bone marrow using photon-counting computed tomography
Acronym
Understanding changes in bone marrow using PCD-CT
Scientific Title
Investigating radiotherapy effects on changes in bone marrow using photon-counting computed tomography
Scientific Title:Acronym
Investigating changes in bone marrow using PCD-CT
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Hematologic toxicities can be dose-limiting effects in radiotherapy, but the degree of radiotherapy effects on the toxicities have not been elucidated in chemoradiation.This study aims to understand radiotherapy effects on changes in red-bone marrow using NAEOTOM Alpha (photon-counting CT)
Basic objectives2
Others
Basic objectives -Others
Investigation of radiotherapy effects
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Signal intensities of tumor metastasis and normal tissues in the bone-marrow mode
Assessment; pre-treatment, one month, three months and one year after radiotherapy
Key secondary outcomes
Common terminology criteria for adverse events, Hounsfield unit and spectrum of thyroid
Assessment; pre-treatment, one month, three months and one year after radiotherapy
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
Patients who undergo radiotherapy for head and neck cancer at our facility (Public Central Hospital of Matto Ishikawa).
Key exclusion criteria
Patients who are claustrophobic, pregnant or lactating.
Patients who refuse to participate this trial.
We make sure that the burdens and the risks are well explained to the patients.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Yamazaki |
Organization
Central Hospital of Matto Ishikawa
Division name
Department of Radiology
Zip code
924-8588
Address
3-8, Kuramitsu, Hakusan city, Ishikawa prefecture
TEL
076-275-2222
info@mattohp.jp
Public contact
Name of contact person
| 1st name | Kunihiko |
| Middle name | |
| Last name | Yokoyama |
Organization
Central Hospital of Matto Ishikawa
Division name
Department of Radiology
Zip code
924-8588
Address
3-8, Kuramitsu, Hakusan city, Ishikawa prefecture
TEL
076-275-2222
Homepage URL
info@mattohp.jp
Sponsor or person
Institute
Central Hospital of Matto Ishikawa
Institute
Department
Personal name
Funding Source
Organization
Central Hospital of Matto Ishikawa
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
Central Hospital of Matto Ishikawa
Address
3-8, Kuramitsu, Hakusan city, Ishikawa prefecture
Tel
076-275-2222
info@mattohp.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
| 2025 | Year | 10 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study includes all the patients who undergo radiotherapy at our facility (Public Central Hospital of Matto Ishikawa) from October 1st, 2025 to September 30th, 2027, if they meet the inclusion criteria.
Management information
Registered date
| 2025 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066795
