Trial Outcomes & Findings for Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations (NCT NCT02576535)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

10 years

Results posted on

2023-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	Fractionated Stereotactic Radiosurgery The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA). Fractionated stereotactic radiosurgery Leskell gamma unit: FDA approved device
Overall Study STARTED	18
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Fractionated Stereotactic Radiosurgery The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA). Fractionated stereotactic radiosurgery Leskell gamma unit: FDA approved device
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Protocol for Staged Stereotactic Radiosurgery for Large Arteriovenous Malformations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fractionated Stereotactic Radiosurgery n=18 Participants The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA). Fractionated stereotactic radiosurgery Leskell gamma unit: FDA approved device
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	3 participants n=5 Participants
Race/Ethnicity, Customized Black, not of Hispanic-American Origin	4 participants n=5 Participants
Race/Ethnicity, Customized Hispanic-American	4 participants n=5 Participants
Race/Ethnicity, Customized White, not of Hispanic-American Origin	7 participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 years

Outcome measures

Outcome measures
Measure	Fractionated Stereotactic Radiosurgery n=16 Participants The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA). Fractionated stereotactic radiosurgery Leskell gamma unit: FDA approved device
Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Associated With New Neurological Symptoms	2 participants

PRIMARY outcome

Timeframe: 10 years

Outcome measures

Outcome measures
Measure	Fractionated Stereotactic Radiosurgery n=16 Participants The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA). Fractionated stereotactic radiosurgery Leskell gamma unit: FDA approved device
Number of Participants With Presence of New Neurological Symptoms Without Evidence of MRI Abnormalities	2 participants

PRIMARY outcome

Timeframe: 10 years

Outcome measures

Outcome measures
Measure	Fractionated Stereotactic Radiosurgery n=16 Participants The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA). Fractionated stereotactic radiosurgery Leskell gamma unit: FDA approved device
Number of Participants Experiencing Hemorrhage From the Arteriovenous Malformation (AVM)	4 participants

PRIMARY outcome

Timeframe: 10 years

Outcome measures

Outcome measures
Measure	Fractionated Stereotactic Radiosurgery n=16 Participants The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA). Fractionated stereotactic radiosurgery Leskell gamma unit: FDA approved device
Number of Participants With Complete Occlusion of AVM on Serial MRI Confirmed With Angiography	15 participants

SECONDARY outcome

Timeframe: 10 years

Outcome measures

Outcome measures
Measure	Fractionated Stereotactic Radiosurgery n=16 Participants The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA). Fractionated stereotactic radiosurgery Leskell gamma unit: FDA approved device
Number of Participants With Presence of T2 Weighted Changes on Serial MRI Exam Not Associated With Neurological Symptoms	3 participants

POST_HOC outcome

Timeframe: 10 years

Outcome measures

Outcome measures
Measure	Fractionated Stereotactic Radiosurgery n=16 Participants The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA). Fractionated stereotactic radiosurgery Leskell gamma unit: FDA approved device
Number of Participants Experiencing Seizures	3 participants

Adverse Events

Fractionated Stereotactic Radiosurgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Huang

NYU Langone Medical Center

Phone: 212-263-6414

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place