CV01-delivered ultrasound for Glioma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Northwell, Lake Success, NY
Glioma+1 More
CV01-delivered ultrasound - Device
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

1 of 3

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

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
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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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.