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

Email



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


Email



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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name