Laser Therapy for Brain Tumor

Overseen By PNOC Operations Office

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Investigational agents

Disqualifiers: Optic pathway gliomas, Spinal tumors, Uncontrolled leptomeningeal disease, others

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

Compensation: Varies

Number of Visits: 14

Duration: Immediate post-procedure

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to evaluate the efficacy of Laser Interstitial Thermal Therapy (LITT) in treating recurrent or progressive, low-grade gliomas (LGG) in pediatric, adolescent and young adult patients.

Who Is on the Research Team?

Sabine Mueller, MD, PhD

Principal Investigator

University of California, San Francisco

Margaret Shatara

Principal Investigator

Children's Minnesota

Are You a Good Fit for This Trial?

Inclusion Criteria

My tumor is 5 cm or smaller, not counting any cysts.

I finished my last biologic or small molecule therapy at least 7 days ago.

My suprasellar glioma did not start in the optic pathway.

Exclusion Criteria

I do not have tumors in areas where LITT is unsafe, like the optic pathway or spinal cord.

I do not have uncontrolled brain or body disease, severe brain swelling, or serious tumor bleeding.

Participants who are receiving any other investigational agents.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Laser Interstitial Thermal Therapy (LITT) and are monitored for immediate complications and recovery progress

Immediate post-procedure

Safety follow-up visits at 14 and 28 days post-procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, with imaging and questionnaires at 3 months, 1 year, and 2 years post-treatment

24 months

Regular follow-up visits and imaging

Long-term follow-up

Participants are transitioned to the PNOC COMP protocol and followed until death or withdrawal from the study

What Are the Treatments Tested in This Trial?

Interventions

• Laser Interstitial Thermal Therapy (LITT)

How Is the Trial Designed?

Group I: Experiment: Laser Interstitial Thermal Therapy (LITT) Experimental Treatment 3 Interventions

Participants will receive LITT and imaging and complete a set of questionnaires pre- and again at 3 months, 1 year, and 2 years post-treatment post- procedure. Participants will be closely monitored for any immediate complications and recovery progress, with a safety follow-up visit scheduled at 14 and 28 days after the LITT procedure. Imaging data from the medical record will also be obtained for up to 24 months and participants will also be co-enrolled in the PNOC COMP protocol, with follow-up procedures documented under this protocol until death or withdrawal from the study.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Pacific Pediatric Neuro-Oncology Consortium

Collaborator

Trials

16

Recruited

840+