Clinical Trial: Bevacizumab Therapy for Brain Arteriovenous Malformation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Bevacizumab Therapy for Brain Arteriovenous Malformation

Brief Summary: Bevacizumab Therapy for brain arteriovenous malformation that is not amenable to surgical intervention.

Detailed Summary: Brain AVMs are relatively rare, though their potential for ICH along with the existence of effective treatments makes their diagnosis and management essential to the community. The 2-4% annual incidence of such secondary ICH creates controversy regarding treatment for asymptomatic patients. Brain AVMs thus require multidisciplinary evaluation for optimal management especially for surgical grades III - V lesions that often require some combination of embolization, microsurgery, and/or radiosurgical treatment. Currently there is no designated medical therapy for bAVM, though there is growing animal and human evidence supporting a role for bevacizumab to reduce the size of AVMs in the brain and liver, respectively. This proposal is a pilot study to assess the efficacy and safety of bevacizumab in humans with bAVMs.
Sponsor: University of California, San Francisco

Current Primary Outcome: Our primary outcome will be change in AVM volume from pre-treatment MRI. [ Time Frame: 12, 26 and 52 weeks ]

AVM volume will be assessed by review of standardized 1.5 mm slices in the axial plane. The contour of the vascular mass using time-of-flight MR angiography sequences will generate a cross-sectional area at each slice level. The volume will be estimated by summing the imputed volume of each slice. This is the standard method in radiation oncology used to assess bAVM volume for radiosurgery treatment planning using commercial software (Leksell GammaPlan). The source images and measurement images will be archived on a research workstation. After a baseline MR examination, follow-up MRs will be performed at 12, 26 and 52 weeks.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Serum VEGF levels [ Time Frame: at baseline and at 12, 26 and 52 weeks ]
  • Urine analysis [ Time Frame: at baseline and at 12, 26 and 52 weeks ]
  • Physical exam [ Time Frame: at baseline and at 12, 26 and 52 weeks ]


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: November 25, 2014
Date Started: June 2016
Date Completion: July 2018
Last Updated: June 2, 2016
Last Verified: June 2016