Active — Not RecruitingNot Applicable

DSC-MRI in Measuring rCBV for Early Response to Bevacizumab in Patients With Recurrent Glioblastoma

United States146 participantsStarted 2017-07-25

Plain-language summary

This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient?s response to treatment.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically proven intracranial glioblastoma or gliosarcoma at initial surgery * Patients will be eligible if the original histology was low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma is made (high-grade transformation) * Karnofsky performance status \>= 70 * Women must not be pregnant or breast-feeding * Progression of disease assessed by local site using Revised Assessment in Neuro-Oncology (RANO) criteria, with plan to give whole-dose bevacizumab therapeutically, either as single therapy or in conjunction with other chemotherapeutic regimens; patients getting bevacizumab to support additional radiation therapy or immunotherapy, or primarily for reduction of edema rather than for tumor treatment, are excluded; this must be the patient?s initial recurrence * Patient must not have been treated previously with immunotherapies (vaccines, checkpoint inhibitors, T-cells) * Intratumoral hemorrhage (acute, subacute, or chronic) as seen on hemosiderin-sensitive (gradient-echo) MRI may preclude patient inclusion because of anticipated limited evaluation due to magnetic susceptibility artifact on the heavily T2-weighted DSC-MRI images; if the region of enhancing tumor not affected by blooming artifact on the hemosiderin-sensitive images does not meet the 10 x 10 x 10 mm ?measurable enhancement? threshold specified elsewhere, the patient is ineligible * Progressive enhancement (\> 25% increase in contrast enhancing volume compare…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is using a specific MRI technique called DSC-MRI to measure blood flow in my tumor after bevacizumab treatment — could you explain what that means for me in terms of extra scans, and whether this imaging approach might give us useful information about how my tumor is responding earlier than standard MRI?
2Since this study is 'active not recruiting,' it's no longer enrolling new patients — are there similar trials or imaging studies currently open that I could still be considered for, or is bevacizumab with standard monitoring a realistic option for me right now?
3The trial is measuring overall survival as a primary outcome — based on what's been seen so far with bevacizumab in recurrent glioblastoma, how would you honestly describe the potential benefit versus the risks for someone in my situation?
4This trial is listed as Phase NA, which often means it's focused more on testing a measurement tool like DSC-MRI than on proving a treatment works — does that change how you'd weigh this study compared to a Phase 2 or Phase 3 trial that's directly testing a new therapy for recurrent glioblastoma?
5Given that my diagnosis is recurrent glioblastoma, which already means a prior treatment has stopped working, are there standard-of-care options or other open clinical trials you'd recommend I explore alongside or instead of approaches connected to this study?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in rCBV within enhancing tumor

Timeframe: Baseline to 2 weeks

Timeframe: Up to 5 years

Trial details

NCT IDNCT03115333

SponsorECOG-ACRIN Cancer Research Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Gliosarcoma trials