5-ALA + Ultrasound for Brain Cancer

Recruiting at 2 trial locations

Overseen By Alpheus Medical

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alpheus Medical, Inc.

Must not be taking: Phototoxic drugs

Disqualifiers: Pregnancy, Brainstem tumors, Porphyria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

22 Participants Needed

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

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.

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

Group I: 5-ALA with CV01 Experimental Treatment 2 Interventions

5-aminolevulinic acid \[5-ALA\] with CV01-delivered ultrasound

Who Is Running the Clinical Trial?

Alpheus Medical, Inc.

Lead Sponsor

Trials

2

Recruited

40+