CV01-delivered ultrasound for Glioma
Phase-Based Progress Estimates
Effectiveness
Safety
Northwell, Lake Success, NY
Glioma+1 More
CV01-delivered ultrasound - DeviceEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
A Phase 1 Multi-center clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With recurrent High Grade Glioma (HGG)
Eligible Conditions
- Glioma
Treatment Effectiveness
Effectiveness Progress
Other trials for Glioma
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: 12 Months
12 Months
Assessment of Duration of Response (DoR)
Assessment of Overall response rate (ORR)
Assessment of Overall survival (OS)
Assessment of Progression free survival (PFS)
Incidence of adverse events (Safety and Tolerability)
To determine the Maximum Tolerable Duration (MTDu)
Trial Safety
Safety Progress
Other trials for Glioma
Trial Design
1 Treatment Group
5-ALA with CV01
1 of 1
Experimental Treatment
33 Total Participants · 1 Treatment Group
Primary Treatment: CV01-delivered ultrasound · No Placebo Group · Phase 1
5-ALA with CV01Experimental Group · 2 Interventions: CV01-delivered ultrasound, 5 Aminolevulinic Acid · Intervention Types: Device, Drug
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
Closest Location: Northwell · Lake Success, NY
N/AFirst Recorded Clinical Trial
1 TrialsResearching Glioma
0 CompletedClinical Trials
Who is running the clinical trial?
Alpheus Medical, Inc.Lead Sponsor
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You must be willing to comply with study requirements.
You have a supratentorial tumor confined to the supratentorial compartment.
You have received 5-ALA treatment for your cancer within the last 3 years.
You have received 4 weeks of cytotoxic chemotherapy and are aged 18 years or older.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments