Low-dose Intra-arterial Bevacizumab for Edema and Radiation Necrosis Therapeutic Intervention (LIBERTI)

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Norton Healthcare
Study ID
NCT02819479
Phase
PHASE2
Status
Completed

Conditions

  • Radiation Necrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 25% Mannitol — DRUG
    Route of administration: In this study, the first step of the treatment will be performing osmotic blood-brain-barrier disruption with administration of intra-arterial 25% Mannitol into the appropriate cervical artery.
  • Low-dose Intra-arterial Bevacizumab — DRUG
    Route of administration: In this study, the second step of the treatment will be administering intra-arterial targeted bevacizumab into the appropriate cervical artery.

Study Details

To assess the overall safety and efficacy of intra-arterial (IA) bevacizumab for the treatment of radiation necrosis. A single 2.5 mg/kg dose of bevacizumab will be given intra-arterially after osmotic blood-brain-barrier disruption.

Key Dates

First listed
Jun 30, 2016
Start date
Nov 23, 2016
Status verified
May 2022
Primary completion
Jun 6, 2019
Completion
Jun 6, 2019

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Low-dose Intra-arterial Bevacizumab
    A single intra-arterial targeted dose of 2.5 mg/kg bevacizumab will be administered after osmotic blood-brain-barrier disruption with intra-arterial 25% mannitol at rate of 4-12 ml/sec for 30 seconds.

Primary Outcome Measure

Change in Radiation Necrosis and Cerebral Edema After a Single Treatment of Low Dose Intra-arterial Avastin (Bevacizumab) [ Time Frame: Baseline (before treatment), and 3 months and 12 months after single dose intra-arterial Avastin (bevacizumab) ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Kentucky Medical CenterLexingtonKentucky40536-
Norton Brownsboro HospitalLouisvilleKentucky40242-

Find similar trials in Lexington, KY

By research site
University of Kentucky Medical Center· Lexington, KYNorton Brownsboro Hospital· Louisville, KY

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