UMIN-CTR Clinical Trial

Basic information
Public title	Safety of Percutaneous Cryoablation in Patients with Painful Bone and Soft Tissue Tumors: A Single Center Prospective Study (SCIRO-1502)
Acronym	Cryoablation for painful bone and soft tissue tumors (SCIRO-1502)
Scientific Title	Safety of Percutaneous Cryoablation in Patients with Painful Bone and Soft Tissue Tumors: A Single Center Prospective Study (SCIRO-1502)
Scientific Title:Acronym	Cryoablation for painful bone and soft tissue tumors (SCIRO-1502)
Region	Japan

Condition
Condition	Painful bone and soft tissue tumor
Classification by specialty	Orthopedics Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety of percutaneous cryoablation for painful bone and soft tissue tumors.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Number of adverse events (Time Frame: 1 month post-cryoablation)
Key secondary outcomes	Difference in VAS, efficacy, and imagings 1 month after cryoablation

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 Maneuver
Interventions/Control_1	Following percutaneously inserting electrode(IceSeed or IceRod; Galil Medical, Yokneam, Israel), cryoablation for painful bone and soft tissue tumor is performed using CryoHit (Galil Medical); cryoablation is performed in two cycles of maximum 15 minutes freezing and at least 2 minutes thawing.
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	1) Painful bone and soft tissue tumor with resistance of medication. 2) Pathologically confirmed painful bone and soft tissue tumor. 3) Target lesion is evaluated with imagings. 4) Life expectancy >= 1 month. 5) Written informed consent. 6) Patient's age is more than 20 years old. 7) Not a candidate for surgery or refuse surgery.
Key exclusion criteria	1) Vital organ and/or vessel on the needle route. 2) Patient has the following comorbidities. a) Heart failure (NYHA >= III) b) Active infection except for virus hepatitis 3) Body temperature of 38 degree or more. 4) Target lesion is not able to be evaluated with imagings. 5) Pregnant. 6) Worse bone fracture caused by cryoablation. 7) Worse quality of life caused by cryoablation. 8) Inadequate cardiac, hepatic, renal, respiratory, coagulation, and bone marrow functions. 9) Not eligible determined by the responding physician.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Toshihiro Middle name Last name Iguchi
Organization	Okayama University Hospital
Division name	Department of Radiology
Zip code	7008558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL	+81-86-235-7315
Email	susumu@cc.okayama-u.ac.jp

Public contact
Name of contact person	1st name Toshihiro Middle name Last name Iguchi
Organization	Okayama University Hospital
Division name	Department of Radiology
Zip code	7008558
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city
TEL	+81-86-235-7313
Homepage URL
Email	iguchi@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	JAPAN SOCIETY FOR THE PROMOTION OF SCIENCE
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Dept. of Radiology, Okayama University Medical School
Address	2-5-1 Shikata-cho, Kita-ku, Okayama city
Tel	+81-86-235-6503
Email	radiol@cc.okayama-u.ac.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	2015 Year 12 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	Terminated
Date of protocol fixation	2015 Year 09 Month 19 Day
Date of IRB	2015 Year 09 Month 26 Day
Anticipated trial start date	2015 Year 12 Month 01 Day
Last follow-up date	2018 Year 12 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 09 Month 19 Day
Last modified on	2020 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022057