UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009906 |
|---|---|
| Receipt number | R000011601 |
| Scientific Title | Safety and Clinical Outcomes of Percutaneous Cryoablation for Musculoskeletal Tumor: a Phase-II Clinical Study |
| Date of disclosure of the study information | 2013/01/30 |
| Last modified on | 2019/03/25 19:22:04 |
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Basic information
Public title
Safety and Clinical Outcomes of Percutaneous Cryoablation for Musculoskeletal Tumor: a Phase-II Clinical Study
Acronym
Percutaneous Cryoablation for Musculoskeletal Tumor
Scientific Title
Safety and Clinical Outcomes of Percutaneous Cryoablation for Musculoskeletal Tumor: a Phase-II Clinical Study
Scientific Title:Acronym
Percutaneous Cryoablation for Musculoskeletal Tumor
Region
| Japan |
Condition
Condition
musculoskeletal tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This prospective study is undertaken to evaluate the safety and outcomes of cryoablation in patients with musculoskeletal tumors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The primary endpoint is safety that is evaluated by Common Terminology Criteria for Adverse Events (CTCAE ver 4.0).
Key secondary outcomes
The secondary endpoints are changes in visual analogue scale (VAS) score, tumor response, and survival.
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
All procedures are performed under real-time CT fluoroscopic guidance. After the patient is placed on the CT couch in the supine, prone, or lateral position, cryoprobes are consecutively placed with 1-2cm interval in the tumor based on the tumor size and location directly or through an bone biopsy needle.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria of this study are as follows: musculoskeletal tumor measuring 5.0 cm or less without regard to pain; age of 20 years or more; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3; adequate main organ function; and a life expectancy of 1 month or longer. Patients have either single tumor or multiple tumors.
Key exclusion criteria
Exclusion criteria is an abnormal coagulability as defined by platelet count of less than 50,000/mm3, and an international normalized ratio (INR) of greater than 1.5.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Yamakado |
Organization
Mie University School of Medicine
Division name
Department of Radiology
Zip code
Address
2-174 Edobashi, Tsu city, Mie Prefecture, Japan
TEL
+81-59-231-5029
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichiro Yamakado |
Organization
Mie University School of Medicine
Division name
Department of Radiology
Zip code
Address
2-174 Edobashi, Tsu city, Mie Prefecture, Japan
TEL
+81-59-231-5029
Homepage URL
Sponsor or person
Institute
Department of Radiology, Mie University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Radiology, Mie University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 01 | Month | 30 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 30 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011601
