UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027828 |
|---|---|
| Receipt number | R000031848 |
| Scientific Title | Phase 1 Clinical Trial of Percutaneous Cryoablation for Painful Musculoskeletal Tumor |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2018/12/20 15:48:49 |
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Basic information
Public title
Phase 1 Clinical Trial of Percutaneous Cryoablation for Painful Musculoskeletal Tumor
Acronym
Phase 1 Trial of Cryoablation for Painful MSK tumor
Scientific Title
Phase 1 Clinical Trial of Percutaneous Cryoablation for Painful Musculoskeletal Tumor
Scientific Title:Acronym
Phase 1 Trial of Cryoablation for Painful MSK tumor
Region
| Japan |
Condition
Condition
Painful Muscloskeletal tumor (osteoid osteoma, metastatic MSK tumor)
Classification by specialty
| Orthopedics | Radiology | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of percutaneous cryoablation for paiful MSK tumor
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety (Within 1 month after the treatment)
Key secondary outcomes
Frequency and degree of the adverse event, Short-term efficacy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Percutaneous Cryoablation
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) Pathological and clinical diagnosis for Musculoskeletal tumor
2) Target lesion was detected by MRI or CT
3) Pain was difficult to be controlled by conservative treatment
4) Pain due to the lesion of at least 5 on a Numerical rating scale (NRS)
5) Adequate cardiac, hepatic, renal, respiratory, coagulation, and bone marrow functions
6) Performance status (ECOG): 0-2
7) Survival time was expected at least 4 weeks
8) Written informed consent from the patient or the delegate
Key exclusion criteria
1) Association between tumor and pain is unclear
2) There was a major neurovascular structure in and around the needle access or the planned ablation area
3) Tumor could not be detected by MRI or CT
4) Bleeding tendency and coagulation disorder were observed clinically.
5) Difficult to stop anti-coagulant drug
6) Active infection and inflammatory disease
7) Over 38 degree fever
8) Patients were confirmed or suspected to be pregnant
9) Attending physician judged the patient was not appropriate for this study
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaya Miyazaki |
Organization
Gunma University Hospital
Division name
Diagnostic and Interventional Radiology
Zip code
Address
3-39-15, Showa-machi, Maebashi, Gunma
TEL
027-220-7111
mmiyazak@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya Miyazaki |
Organization
Gunma University Hospital
Division name
Diagnostic and Interventional Radiology
Zip code
Address
3-39-15, Showa-machi, Maebashi, Gunma
TEL
027-220-7111
Homepage URL
mmiyazak@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gunma University Hospital
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
Address
Tel
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
| 2017 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 20 | Day |
Last modified on
| 2018 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031848
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
