UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057147 |
|---|---|
| Receipt number | R000065307 |
| Scientific Title | Verifying photon-counting computed tomography abilities to characterize and localize bone metastasis |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/05/29 16:16:05 |
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Basic information
Public title
Understanding bone metastasis using photon-counting computed tomography
Acronym
PCD-CT trial for bone metastasis
Scientific Title
Verifying photon-counting computed tomography abilities to characterize and localize bone metastasis
Scientific Title:Acronym
PCD-CT trial for bone metastasis
Region
| Japan |
Condition
Condition
Bone metastasis
Classification by specialty
| Medicine in general | Surgery in general | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Conventional computed tomography (CT) has difficulties of localizing and characterizing bone metastasis precisely. On the other hand, photon-counting CT utilizes a novel detector, which enables higher spatial resolution for imaging and spectrum sequences based on the ability, including bone marrow mode. Our study aims to verify the photon-counting CT abilities to localize and characterize bone metastasis.
Basic objectives2
Efficacy
Basic objectives -Others
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 and three months after radiotherapy
Key secondary outcomes
Tumor spread on plain CT images
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Scanning metastatic lesions with photon-counting CT
Pre-treatment, one month and three months after radiotherapy
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with bone metastasis who undergo radiotherapy at our facility (Public Central Hospital of Matto Ishikawa).
Key exclusion criteria
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
10
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
08030470658
abearinthewoods_0419@yahoo.co.jp
Public contact
Name of contact person
| 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
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 | 02 | Month | 27 | 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 | 02 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065307
