UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007867
Receipt number R000008676
Scientific Title research on the efficacy of radiation therapy for prevention of the growth of giant and/or thrombosed cerebral aneurysm
Date of disclosure of the study information 2012/06/01
Last modified on 2019/06/04 16:49:02

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Basic information

Public title

research on the efficacy of radiation therapy for prevention of the growth of giant and/or thrombosed cerebral aneurysm



Acronym

radiation therapy for giant and/or thrombosed cerebral aneurysm

Scientific Title

research on the efficacy of radiation therapy for prevention of the growth of giant and/or thrombosed cerebral aneurysm



Scientific Title:Acronym

radiation therapy for giant and/or thrombosed cerebral aneurysm

Region

Japan


Condition

Condition

giant and/or thrombosed cerebral aneurysms that grow after surgical treatment

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the safety and efficacy of radiation therapy for surgically-treated growing giant and/or thrombosed cerebral aneurysms

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I


Assessment

Primary outcomes

growth of aneurysm
rupture of aneurysm

Key secondary outcomes



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

Educational,Counseling,Training

Type of intervention

Maneuver

Interventions/Control_1

Hypofractionated Stereotactic Radiation Therapy
35Gy/5fr.

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)unruptured giant and/or thrombosed aneurysms not applicable to direct or endovascular surgery
2)aneurysmal grwoth was confirmed with CT or MRI
3)wrriten informed consent

Key exclusion criteria

1)ruptured aneurysms
2)history of radiation therapy or in radiation therapy for head disease
3)patients associated with stenotic cerebral artery in the vicinity of aneurysm

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Susumu
Middle name
Last name Miyamoto

Organization

Kyoto university Graduate School of Medicine

Division name

Neurosurgery

Zip code

606-8507

Address

54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan

TEL

075-751-3653

Email

miy@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name Kazuimichi
Middle name
Last name Yoshida

Organization

Kyoto university Graduate School of Medicine

Division name

Neurosurgery

Zip code

606-8507

Address

54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan

TEL

075-751-3459

Homepage URL


Email

kazuy@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Neuosurgery, Kyoto university Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

Kyoto University Hospital Ethics Committe

Address

54 Kawahara-cho Shogoin Sakyo-ku, Kyoto, 606-8507 Japan

Tel

075-753-4680

Email

ethcom@kuhp.kyoto-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

京都大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2012 Year 06 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

2012 Year 04 Month 02 Day

Date of IRB

2012 Year 06 Month 07 Day

Anticipated trial start date

2012 Year 06 Month 07 Day

Last follow-up date

2020 Year 06 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 05 Month 01 Day

Last modified on

2019 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008676


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name