Actively Recruiting
Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma
Led by University of Miami · Updated on 2025-08-01
96
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this research is to find hidden cancer with an experimental magnetic resonance imaging (MRI) scan called spectroscopic magnetic resonance imaging (sMRI). That spectroscopic MRI scan will be used to increase the area of the brain receiving radiation and then the dose of radiation in attempt to kill more of the cancer. Proton radiotherapy and bevacizumab (Avastin) are used to minimize the possible side effects of this approach.
CONDITIONS
Official Title
Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of recurrent glioblastoma or gliosarcoma confirmed by MRI, biopsy, resection, or advanced imaging techniques
- Pathology diagnosis based on 2021 WHO glioblastoma criteria
- Maximum tumor recurrence size of 6 cm or less on MRI
- Prior brain radiation therapy with conventional fractionation (1.8 - 2 Gy per fraction, max total 63 Gy)
- Completed prior brain radiation at least 4-6 months before study treatment depending on tumor location
- Minimum time elapsed since any prior anti-tumor or investigational agents (28 days or 5 half-lives)
- Age 18 years or older
- Ability to undergo MRI scans
- Able to provide written informed consent
- ECOG performance status of 0-2
- Life expectancy greater than 12 weeks
- Negative pregnancy test for females unless menopausal or surgically sterile
- Agreement to use effective contraception for men and women with childbearing potential during treatment and 6 months after
- Adequate blood counts, liver, and kidney function within 21 days prior to registration
- Patients on full-dose anticoagulants must have no active bleeding and stable INR within 21 days prior to registration
You will not qualify if you...
- Brain malignancies other than glioblastoma or variants (benign lesions allowed)
- Glioma without prior standard first-line therapies including initial radiation
- Glioma with prior second course of radiation therapy
- Multifocal disease across multiple brain lobes (multiple nodules in one region allowed if ≤6 cm)
- Previous treatment with Bevacizumab
- Concurrent chemotherapy other than Bevacizumab
- Tumors in brain regions with known MRI signal issues
- Pregnant or breastfeeding
- Prior invasive malignancy unless disease-free for 1 year
- Severe active comorbidities including recent heart problems, stroke, vascular disease, infections, respiratory illness, liver insufficiency, or AIDS
- Women or men unwilling or unable to use contraception
- Prior allergic reaction to Bevacizumab
- History of hypertensive crisis or encephalopathy
- Non-healing wounds, ulcers, or fractures within 3 months
- Recent significant bleeding events
- Recent major surgery or trauma (except craniotomy)
- Concurrent use of other investigational agents
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
Z
Zuzel Rodriguez
CONTACT
J
Jonathan Bell, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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