GBM study: Definity® Vial for
Official title Focused Ultrasound Blood-Brain Barrier Disruption for the Treatment of High-Grade Glioma in Patients Undergoing Standard Chemotherapy
ClinicalTrials.gov ID: NCT07179328
What this study is testing
What is Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension?
Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for gbm.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if using focused ultrasound to temporarily open the blood‑brain barrier is safe and doable for patients on maintenance temozolomide therapy.
- Who it's for
- Adults with glioblastoma who are currently in the maintenance phase of the standard Stupp chemotherapy protocol.
- What's involved
- Participants will have repeated focused‑ultrasound sessions with an IV contrast agent, undergo MRI scans and clinical exams, and give blood samples (and tumor tissue if available) for analysis.
- Time commitment
- The trial runs throughout the maintenance chemotherapy period with multiple ultrasound and MRI visits, followed by routine check‑ups until disease progression or end of life.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Age between 18 and 85 years, inclusive.
- Able and willing to provide written informed consent.
- Diagnosis of Glioblastoma by histology or molecular markers based on WHO 2021 classification.
- Previously undergone a maximal safe surgical resection and completed concurrent, standard-of-care RT and TMZ without any complications and deemed...
- Tumor or tumor resection cavity is clearly defined on screening MRI scans.
You likely can't join if
- Patients presenting with the following imaging characteristics: i. Following steroid treatment, brain edema and/or mass effect that causes midline...
- The sonication pathway to the tumor involves: i. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp...
- The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).
- Patients requiring increasing doses of corticosteroids.
- Patient receiving bevacizumab (Avastin) therapy.
- Patients with ≥25% increase in volume of contrast enhancement at time of assessment for study enrollment, compared with their first postoperative...
See the full eligibility criteria
- Age between 18 and 85 years, inclusive.
- Able and willing to provide written informed consent.
- Diagnosis of Glioblastoma by histology or molecular markers based on WHO 2021 classification.
- Previously undergone a maximal safe surgical resection and completed concurrent, standard-of-care RT and TMZ without any complications and deemed eligible for the maintenance phase of TMZ treatment.
- Tumor or tumor resection cavity is clearly defined on screening MRI scans.
- Karnofsky Performance Score rating 70-100.
- American Society of Anesthesiologists (ASA) physical status score of 1-3.
- Life expectancy of at least 3 months and able to attend all study visits.
- Patients presenting with the following imaging characteristics: i. Following steroid treatment, brain edema and/or mass effect that causes midline shift or shift in wall of the third ventricle of more than 10 mm. ii.
- The sonication pathway to the tumor involves: i. More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp. ii.
- The subject presents with symptoms and signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, and papilledema).
- Patients requiring increasing doses of corticosteroids.
- Patient receiving bevacizumab (Avastin) therapy.
- Patients with ≥25% increase in volume of contrast enhancement at time of assessment for study enrollment, compared with their first postoperative MRI.
- Patients undergoing other concurrent therapies such as chemotherapy wafers, immunotoxins delivered by convection-enhanced delivery, regionally administered gene and viral therapies, immunotherapies, and focal...
- Cardiac disease or unstable hemodynamics including: i. Documented myocardial infarction within six months of enrollment. ii. Unstable angina on medication. iii. Congestive heart failure. iv.
- Severe hypertension (diastolic blood pressure (DBP) \> 100 on medication).
- Anti-coagulant therapy, or medications known to increase risk of hemorrhage within washout period prior to treatment (i.e., antiplatelet or vitamin K inhibitor anticoagulants within 7 days, non-vitamin K inhibitor...
- History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor hemorrhage.
- Abnormal level of platelets (\ 1.3.
- Documented cerebral infarction within the past 12 months.
- TIA in the last 1 month.
- Cerebral or systemic vasculopathy.
- Insulin-dependent diabetes mellitus that is not well-controlled or that in the Investigator's opinion precludes participation in the study.
- Known sensitivity to gadolinium-DTPA.
- Known sensitivity to DEFINITY® ultrasound contrast agent or perflutren.
- Contraindications to MRI such as non-MRI-compatible implanted devices, unable to tolerate an MRI due to for instance pain or claustrophobia, untreated, uncontrolled sleep apnea.
- Positive pregnancy test (for pre-menopausal women).
- Known life-threatening systemic disease.
- Severely impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73m2 and/or on dialysis.
- Right to left or bi-directional cardiac shunt.
- Previous full course of chemotherapy for GBM (at the discretion of investigator).
- Previous radiotherapy.
- Allergy to eggs or egg products.
- people with evidence of cranial or systemic infection.
- people with chronic pulmonary disorders.
- people with a history of drug allergies, asthma or hay fever, and multiple allergies, in particular people with a history of anaphylaxis.
- people with a family or personal history of QT prolongation or taking concomitant medications known to cause QTc prolongation, or QT prolongation observed on screening ECG (QTc \> 450 for men and \>470 for women).
- people with evidence of Hepatitis B virus infection/carrier state.
- Liver injury as indicated by liver function tests that in the Investigator's opinion precludes participation in the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Toronto, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.