UMIN-CTR Clinical Trial

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
Email	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
Email	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
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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

Contact us.