Efficacy of stereotactic radiosurgery based on three-dimensional rotational angiography for cerebrovascular malformation

JRCT ID: jRCT1032230589

Registered date:23/01/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Brain arteriovenous malformation
• Date of first enrollment: 23/01/2024
• Target sample size: 60
• Study type: Interventional
• Intervention(s): The intervention of stereotactic radiosurgery with Gamma Knife, integrating images of three-dimensional rotational angiography into radiosurgical planning.

Outcome(s)

• Primary Outcome: The cumulative complete obliteration rates of nidus for 5 years after stereotactic radiosurgery

Secondary Outcome

(1) Period achieving complete obliteration of nidus after stereotactic radiosurgery
(2) Hemorrhage after stereotactic radiosurgery
(3) Intervention-free survival after stereotactic radiosurgery
(4) Disease-specific survival after stereotactic radiosurgery
(5) Perifocal edema around the nidus after stereotactic radiosurgery
(6) Neurological status

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Inclusion criteria are as follows:

(1) Individuals in whom a brain arteriovenous malformation (BAVM) has been identified by head MRI examination.
(2) Age: Individuals who are 5 years old or older but under 80 years old at the time of consent acquisition.
(3) Gender: Not specified.
(4) Individuals who have received sufficient explanation about participating in this study, have understood it fully, and have given their written consent freely either personally or through a representative.
(5) Individuals who are able to attend outpatient visits in accordance with the research implementation schedule.

Exclude criteria

Individuals meeting any of the following exclusion criteria will be excluded from the study:

(1) Those with large lesions (volume over 20cm^3) requiring multiple treatments (staged treatment).
(2) Individuals unable to give consent or assent due to impaired consciousness.
(3) Those with serious renal dysfunction.
(4) Individuals with a history of serious drug allergies such as anaphylactic shock or a history of serious side effects.
(5) Those who have participated in clinical trials or research studies and taken experimental drugs within 4 weeks prior to consent acquisition.
(6) Individuals planning to undergo radiation therapy for the same lesion or other intracranial lesions during the period from the time of consent acquisition until the end of the study period.
(7) Pregnant individuals or those suspected to be pregnant.
(8) Others whom the research director or participating physician deems inappropriate for participation in this study

Related Information

• Primary Sponsor: Umekawa Motoyuki