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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000027828 |
Receipt No. | 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 |
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 |
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Condition | |||||
Condition | Painful Muscloskeletal tumor (osteoid osteoma, metastatic MSK tumor) | ||||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 18 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Gunma University Hospital |
Institute | |
Department |
Funding Source | |
Organization | Gunma University Hospital |
Organization | |
Division | |
Category of Funding Organization | Other |
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Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.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 | |
Registered date | File name |