18 and older, any sex, with Radiation Necrosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Radiation Necrosis and Cerebral Edema After a Single Treatment of Low Dose Intra-arterial Avastin (Bevacizumab)Primary· Baseline (before treatment), and 3 months and 12 months after single dose intra-arterial Avastin (bevacizumab)
Imaging response to therapy will be quantitatively assessed on MRI using volumetric analysis. Regions of T2 and FLAIR prolongation above contralateral white matter will be calculated and quantified in cubic centimeters. Region of interest (ROI) will be created using a semi-automated, thresholding and region-growing technique. Enhancement of the lesion will be calculated using similar volumetric ROI analysis with a contrast threshold of 40% above background and measured in cubic centimeters.
Vol EDEMA at Baseline
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
86.8
± 95.9
Vol EDEMA at 3 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
38.6
± 37.5
Vol EDEMA at 12 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
32.6
± 33.7
Vol Radiation Necrosis at Baseline
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
14.5
± 12.1
Vol Radiation Necrosis at 3 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
6.6
± 7.5
Vol Radiation Necrosis at 12 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
3.2
± 3.3
Change in Headache Associated Morbidity Measured With MIDAS TOTAL SCORE After a Single Treatment of Low Dose Intra-arterial Avastin (Bevacizumab) Will be Measured.Secondary· Baseline (before treatment), and 6 weeks, 3 months, 6 months, 9 months, and 12 months after single dose intra-arterial Avastin (bevacizumab)
We will determine how severely headache affect the patient's life before and after treatment by performing the Migraine Disability Assessment (MIDAS) questionnaire. MIDAS TOTAL SCORE is the sum of Items 1 through 5. A Total Score of 0-5 signifies little or no disability, score of 6-10 signifies mild disability, score of 11-20 signifies moderate disability, and score of 21+ signifies severe disability. The theoretical maximum score would be 450.
MIDAS TOTAL at Baseline
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
81.7
± 110.1
MIDAS TOTAL at 6 weeks
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
49.7
± 66.6
MIDAS TOTAL at 3 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
22.1
± 30.3
MIDAS TOTAL at 6 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
28.3
± 46.2
MIDAS TOTAL at 9 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
24.4
± 33.7
MIDAS TOTAL at 12 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
15.6
± 26.5
Change in Headache Associated Morbidity Measured With MIDAS DAYS of HEADACHE After a Single Treatment of Low Dose Intra-arterial Avastin (Bevacizumab) Will be Measured.Secondary· Baseline (before treatment), and 6 weeks, 3 months, 6 months, 9 months, and 12 months after single dose intra-arterial Avastin (bevacizumab)
We will determine how severely headache affect the patient's life before and after treatment by performing the Migraine Disability Assessment (MIDAS) questionnaire. MIDAS DAYS of HEADACHE is Item 6 of the questionnaire which sums total number of days the patient had headache symptoms over the past 3 months regardless of headache severity or resultant disability. Min score of 0 days is the best possible score. Max Score of 90 days is worse possible score, meaning the patient experienced headache pain every day over past 3 months.
MIDAS DAYS of HEADACHE at Baseline
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
33.3
± 29.8
MIDAS DAYS of HEADACHE at 6 weeks
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
25.8
± 35.0
MIDAS DAYS of HEADACHE at 3 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
9.0
± 9.3
MIDAS DAYS of HEADACHE at 6 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
14.6
± 14.1
MIDAS DAYS of HEADACHE at 9 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
12.4
± 17.6
MIDAS DAYS of HEADACHE at 12 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
11.5
± 17.0
Change in Headache Associated Morbidity Measured With MIDAS PAIN LEVEL After a Single Treatment of Low Dose Intra-arterial Avastin (Bevacizumab) Will be Measured.Secondary· Baseline (before treatment), and 6 weeks, 3 months, 6 months, 9 months, and 12 months after single dose intra-arterial Avastin (bevacizumab)
We will determine how severely headache affect the patient's life before and after treatment by performing the Migraine Disability Assessment (MIDAS) questionnaire. MIDAS PAIN LEVEL is Item 7 which rates the 3-month average headache PAIN LEVEL on scale from 0 to 10 where 0 = no pain at all, and 10 = pain as bad as it can be.
MIDAS PAIN LEVEL at Baseline
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
6.9
± 2.2
MIDAS PAIN LEVEL at 6 weeks
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
6.4
± 1.8
MIDAS PAIN LEVEL at 3 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
4.7
± 2.9
MIDAS PAIN LEVEL at 6 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
5.0
± 2.9
MIDAS PAIN LEVEL at 9 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
4.8
± 3.0
MIDAS PAIN LEVEL at 12 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
4.8
± 3.5
Change in Headache Measured With Headache Impact Test (HIT-6) After a Single Treatment of Low Dose Intra-arterial Avastin (Bevacizumab)Secondary· Baseline (before treatment), and 6 weeks, 3 months, 6 months, 9 months, and 12 months after single dose intra-arterial Avastin (bevacizumab)
Quantitative change in headache will be assessed by performing the Headache Impact Test (HIT-6), which is a fixed-length 6-item questionnaire. The score for this questionnaire can range from 36 to 78, with 36 indicating minimum headache impact and the max score of 78 indicating worst possible headache impact.
Headache Impact Test-6, Baseline
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
62.4
± 7.5
Headache Impact Test-6, 6 Weeks
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
54.5
± 11.4
Headache Impact Test-6, 3 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
52.3
± 13.0
Headache Impact Test-6, 6 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
53.3
± 13.6
Headache Impact Test-6, 9 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
53.2
± 15.4
Headache Impact Test-6, 12 months
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
52.1
± 14.4
Change in Functional Status After a Single Treatment of Low Dose Intra-arterial BevacizumabSecondary· Baseline (before treatment), Day 1, and at 3 months, and 12 months after single dose intra-arterial Avastin (bevacizumab)
Quantitative change in functional status will be assessed by performing Karnofsky Performance Status Scale (KPS). The KPS score can range from 0 to 100 where 0 is dead and 100 is fully alive and normal with no complaints and no evidence of disease.
Karnofsky at Baseline
Group
Value
95% CI
Low-dose Intra-arterial Bevacizumab
79.0
± 9.9
Karnofsky at Day 1
Group
Value
95% CI
Low-dose Intra-arterial Bevacizumab
81.0
± 7.4
Karnofsky at Month 3
Group
Value
95% CI
Low-dose Intra-arterial Bevacizumab
83.0
± 11.6
Karnofsky at Month 12
Group
Value
95% CI
Low-dose Intra-arterial Bevacizumab
86.3
± 7.4
Change in Steroid Usage After a Single Treatment of Low Dose Intra-arterial Avastin (Bevacizumab)Secondary· 12 months prior to single dose of IA bevacizumab; 12 months following single dose of IA bevacizumab
To assess the utility of intra-arterial (IA) bevacizumab treatment in allowing decreased steroid usage, total cumulative days of steroid usage were compared between the 12 months PRIOR TO and the 12 months IMMEDIATELY FOLLOWING IA bevacizumab. Days of steroid usage were tabulated via medical history and chart review at the baseline visit for the 12 months prior to IA bevacizumab and post-treatment on days 0 and 1, week 6, and months 3, 6, 9 and 12 for the 12 month total after IA bevacizumab treatment. Excluding topical steroid preparations, all days of enteral or parenteral steroid intake of a
12 months PRIOR to IA bevacizumab
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
61.5
0 – 156.25
12 months AFTER IA bevacizumab
Group
Value
95% CI
Low-dose Intra-arterial Avastin (Bevacizumab)
13.0
0 – 87.25
Post-operative Neurocognitive Change After Intra-arterial BevacizumabSecondary· Baseline (before bevacizumab), and 3 months and 12 months after single dose intra-arterial Avastin (bevacizumab)
In order to investigate post-operative changes in Neurocognitive performance after intra-arterial bevacizumab, patients who consented underwent formal neuropsychological battery testing. Sixteen subtests from the Neuropsychological Assessment Battery (Stern \& White, PAR Inc.) were chosen for brevity, sensitivity, and due to the wide range of available normative data (ages 18-97). For each subtest, T-score = 50 is the normative mean with SD = 10. Thus T-scores of 40-60 are within one standard deviation of the mean and are considered generally normal. Scores increasingly below 40 indicate decre
Digits Forward at Baseline
Group
Value
95% CI
Low-dose Intra-arterial Bevacizumab
41.1
± 11.8
Digits Forward at 3 months
Group
Value
95% CI
Low-dose Intra-arterial Bevacizumab
44.1
± 12.2
Digits Forward at 12 months
Group
Value
95% CI
Low-dose Intra-arterial Bevacizumab
42.3
± 11.7
Digits Backward at Baseline
Group
Value
95% CI
Low-dose Intra-arterial Bevacizumab
44.9
± 8.3
Digits Backward at 3 months
Group
Value
95% CI
Low-dose Intra-arterial Bevacizumab
44.9
± 11.9
Digits Backward at 12 months
Group
Value
95% CI
Low-dose Intra-arterial Bevacizumab
40.3
± 13.1
Numbers & Letters SPEED at Baseline
Group
Value
95% CI
Low-dose Intra-arterial Bevacizumab
38.2
± 10.7
Numbers & Letters SPEED at 3 months
Group
Value
95% CI
Low-dose Intra-arterial Bevacizumab
36.7
± 10.8
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Norton Healthcare
Last refreshed: 24 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02819479.