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Photosensitizing Agent
5-ALA + Ultrasound for Brain Cancer
Phase 1
Waitlist Available
Research Sponsored by Alpheus Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥ 18 years of age
Previous histopathologically confirmed diagnosis of high-grade glioma and radiographic evidence of recurrence after prior therapy with radiotherapy. Eligible histologies include (according to WHO classification 2021): Astrocytoma, WHO grade 3 and 4 (including subtypes), Oligodendroglioma WHO grade 3 (including subtypes)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing whether a combination of 5-aminolevulinic acid and CV01 delivery of ultrasound is safe and tolerated in patients with recurrent high grade glioma.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include sensitivity reactions due to the drug or porphyrins, issues related to ultrasound exposure on the skull or brain tissue, and general risks associated with taking investigational treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have a high-grade brain tumor that has come back after radiation treatment.
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My tumor is located in the upper part of my brain.
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My blood tests show normal immune, liver, kidney, and clotting function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (Safety and Tolerability)
To determine the Maximum Tolerable Duration (MTDu)
Secondary outcome measures
Assessment of Duration of Response (DoR)
Assessment of Overall response rate (ORR)
Assessment of Overall survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 5-ALA with CV01Experimental Treatment2 Interventions
5-aminolevulinic acid [5-ALA] with CV01-delivered ultrasound
Find a Location
Who is running the clinical trial?
Alpheus Medical, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.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.I have a high-grade brain tumor that has come back after radiation treatment.I need urgent treatment for severe swelling.My health is quickly getting worse and may not handle early treatment or surgery well.I have received more than 64 Gy of radiation therapy.My cancer is located in the lower part of my brain or brainstem.My cancer originates in my spinal cord.I am aware that I have HIV.I cannot stop taking light-sensitive medications before and after a specific treatment.I am able to understand and follow the study's requirements.I am a man, or a woman not pregnant or breastfeeding, and if capable of becoming pregnant, I agree to use birth control during the study.I am not pregnant or breastfeeding.I have a stomach or intestine problem that affects how my body absorbs food.My glioblastoma has recurred after radiotherapy.My tumor is located in the upper part of my brain.My blood tests show normal immune, liver, kidney, and clotting function.I have not had cancer treatment since my last 5-ALA treatment.I am scheduled for tumor removal surgery, whether or not I join the study.My brain tumor affects both sides of my brain or the area that connects them.I cannot have an MRI or use contrast dyes due to health reasons.You are allergic to 5-ALA or porphyrins.
Research Study Groups:
This trial has the following groups:- Group 1: 5-ALA with CV01
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the present number of participants in this trial?
"Affirmative. According to clinicaltrials.gov, the trial started recruiting on June 29th 2022 and was last revised on October 27th of the same year. Recruitment requires 33 participants from 3 different medical centres."
Answered by AI
Is there a recruitment of participants taking place currently for this research?
"Affirmative, the online database hosted on clinicaltrials.gov attests to this medical trial's active recruitment status. First posted in late June of 2022, the study has since recruited 33 participants from 3 sites."
Answered by AI
Has the FDA sanctioned CV01-delivered ultrasound technology?
"As this is a Phase 1 trial and there is limited data supporting efficacy and safety, the team at Power assigned CV01-delivered ultrasound a score of 1."
Answered by AI
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