Health TrialsbyHealthPanel

Spectroscopic MRI, Proton Therapy, and Avastin for Recurrent Glioblastoma

ConditionRecurrent Glioblastoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

An area of MRI enhancement consistent with glioblastoma outside of the initial high dose radiation field.

Biopsy or resection proven recurrent glioblastoma.

Progressive glioblastoma based on advanced imaging (brain positron emission tomography (PET), perfusion MRI, or clinical MR Spectroscopy)

For "marginal" or "out of field" radiation failures where at least half of the enhancing disease is outside of the prior high dose radiation field but there is field overlap, patients must have completed prior radiation at least four months or more prior to study treatment.

Disqualifiers

Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration.

Transmural myocardial infarction within the last 6 months prior to registration.

History of stroke or transient ischemic attack within 6 months prior to registration.

Significant vascular disease (e.g., aortic aneurysm, history of aortic dissection) or clinically significant peripheral vascular disease.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Intensity Modulated Proton Therapy (IMPT)

    Radiation

    Participants will receive radiation therapy delivered via intensity modulated proton therapy (IMPT) simultaneous integrated boost technique over a period of 10 days, 5 days per week for approximately 2 weeks.

  • Bevacizumab

    Drug

    Bevacizumab will be administered intravenously (IV), beginning at a dose of 10 mg/kg every 2-3 weeks until disease progression.

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Cohort A: sMRI-Guided RT at 35 Gy in 10 fractionsExperimental treatment 2 interventions
Group B: Cohort B: sMRI-Guided RT at 40 Gy in 10 fractionsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of patients for whom sMRI-guided therapy is technically successful

The percentage of participants for whom sMRI-guided therapy is successful will be reported as the percentage of participants who show no significant residual tumor after protocol therapy.

Time frame
About 60 days
2

Incidence of Grade 3 irreversible or any Grade 4/5 neurologic toxicity.

The incidence of irreversible Grade 3 or any Grade 4/5 neurologic adverse events (AEs) or serious adverse events (SAEs) in study participants will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion. Incidence of these toxicities will be reported for both cohorts, Cohort A (sMRI-Guided RT at 35 Gy in 10 fractions) and Cohort B (sMRI-Guided RT at 40 Gy in 10 fractions).

Time frame
Up to 6 months

Secondary outcomes

1

Progression-Free Survival (PFS)

Progression-free Survival (PFS) is defined as the time from the start of radiation therapy to any documented progression or death from any cause, whichever occurs first. Surviving patients without progression will be censored at the date of last contact.

Time frame
Up to 2 years
2

Overall Survival (OS)

Overall Survival (OS) is defined as the time from the start of radiation therapy to date of death from any cause. Surviving patients will be censored at the date of last contact.

Time frame
Up to 2 years
3

Comparison of Cerebral Blood Volumes (CBV) among MRI techniques

Comparison of the cerebral blood volumes (CBV) in participants measured by Spectroscopic MRI (sMRI) versus by conventional MRI and multiparametric MRI (mpMRI). CBV is defined as the volume of blood in a given amount of brain tissue, most commonly milliliters of blood per 100 g of brain tissue.

Time frame
About 3 months
4

Comparison of Apparent Diffusion Coefficients (ADC) among MRI techniques

Comparison of the apparent diffusion coefficients (ADC) in participants measured by Spectroscopic MRI (sMRI) versus by conventional MRI and multiparametric MRI (mpMRI). ADC is a measure of the magnitude of diffusion (of water molecules) within tissue, and is commonly clinically calculated using MRI with diffusion-weighted imaging (DWI). ADC of tissue is expressed in units of mm2/s.

Time frame
About 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov
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