5-ALA + Ultrasound for Brain Cancer
Recruiting at 2 trial locations
AM
Overseen ByAlpheus Medical
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Alpheus Medical, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
This trial is testing a new treatment for aggressive brain tumors using a special drug and a sound wave machine. The drug makes the cancer cells more sensitive to sound waves, which then help to kill the cancer cells. It aims to help patients whose tumors are hard to treat with standard methods.
Eligibility Criteria
Adults over 18 with a confirmed high-grade glioma brain tumor that has recurred after radiotherapy. They must understand the study, be willing to follow its rules, and have good enough health as shown by specific blood tests and organ function measures. Women of childbearing age need a negative pregnancy test and agree to use contraception.Inclusion Criteria
Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days prior to first 5-ALA administration
I have a high-grade brain tumor that has come back after radiation treatment.
Patient must provide informed consent, stating understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements
See 8 more
Exclusion Criteria
I have a type of porphyria.
I do not have any severe health conditions that could affect my participation in the study.
I haven't had a stroke or brain bleeding in the last 6 months not related to brain tumor surgery.
See 15 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 5-ALA as a sonosensitizer prior to CV01-delivered ultrasound, re-administered every 4 weeks
12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Treatment Details
Interventions
- 5 Aminolevulinic Acid
- CV01-delivered ultrasound
Trial Overview The trial is testing the safety of combining a drug called 5-aminolevulinic acid (5-ALA) with CV01-delivered ultrasound for sonodynamic therapy in patients whose aggressive brain tumors have come back after treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: 5-ALA with CV01Experimental Treatment2 Interventions
5-aminolevulinic acid \[5-ALA\] with CV01-delivered ultrasound
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Who Is Running the Clinical Trial?
Alpheus Medical, Inc.
Lead Sponsor
Trials
2
Recruited
40+
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