Efficacy of Laser Interstitial Thermal Therapy in Young Persons With Low-grade Glioma

NCT07506239 | Recruiting DMC FDA Device

• 2 other identifiers: 250828NCI-2026-01278
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low-grade Glioma; Recurrent Low Grade Glioma; Low Grade Glioma of Brain; Pediatric Cancer

Keywords

Interstitial Laser Therapy

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with Progression-free Survival (PFS)

  PFS is defined as proportion of participants who do not experience further disease progression at 15 months following and assessed by MRI according to Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria.

  up to 15 months

Study Arms (1)

Experiment: Laser Interstitial Thermal Therapy (LITT)

EXPERIMENTAL

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.

Device: Laser Interstitial Thermal Therapy (LITT); Procedure: Magnetic resonance imaging (MRI); Other: Questionnaires

Interventions

Laser Interstitial Thermal Therapy (LITT) DEVICE

Perform ablation using LITT

Also known as: LITT

Experiment: Laser Interstitial Thermal Therapy (LITT)

Questionnaires OTHER

Participants will complete questionnaires

Experiment: Laser Interstitial Thermal Therapy (LITT)

Magnetic resonance imaging (MRI) PROCEDURE

Undergo single imaging procedure

Also known as: MRI

Experiment: Laser Interstitial Thermal Therapy (LITT)

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants must have recurrent or progressive pediatric LGG who have received at least one prior treatment. Prior treatment may include surgery alone and/or systemic therapy.
• Participants must have histologically confirmed LGG that is recurrent or progressive after prior treatment and determined to be a candidate for LITT by central review. All patients will undergo central review prior to LITT. Any number of previous recurrences are permissible provided the participant meets other enrollment criteria.
• Tumor size: up to 5 cm in largest dimension not including any cystic component. Larger tumors will need to be discussed with the study team. Additional adjunctive interventions such as cyst aspiration prior to or concurrent with a LITT procedure is allowed at the treating surgeon's discretion.
• Tumor location: Tumors must be located in areas of the brain or central nervous system that are accessible and considered safe for LITT, as determined by central review.
• Suprasellar gliomas not arising from the optic pathway are eligible.
• Multifocal or metastatic LGGs are eligible, provided that the growing lesions are suitable for LITT.
• Exophytic brainstem lesions, which are more accessible and present a lower risk, may be eligible for LITT.
• A patient with stable leptomeningeal disease and a separate growing lesion suitable for LITT is eligible for the study.
• Prior Therapy: Participants may have had LITT for other medical indications, provided that the lesion being considered for this study has not previously undergone LITT, except for patients who have received LITT for an intracranial lesion that has shown progression post-LITT beyond 15 months would be eligible.
• Participants must have fully recovered from the acute toxic effects of all prior chemotherapy or targeted therapy prior to entering this study and would be eligible for surgical intervention per institutional guidelines.
• Bevacizumab: participants must have received last dose \> 21 days prior to study registration.
• Participants must have had chemotherapy \> 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
• Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any agent with known adverse events that can occur beyond 7 days after administration, the period prior to enrollment must be beyond the time during which adverse events are known to occur. Such patients should also be discussed with study chairs.
• Radiation:
• Participants must have:

You may not qualify if:

• Any contraindication to the use of LITT, such as but not limited to:
• Optic pathway gliomas
• Spinal tumors
• Brainstem Lesions: Infiltrative brainstem lesions are excluded. However, exophytic brainstem lesions, which are more accessible and present a lower risk, may be eligible for LITT.
• Any lesion/location determined by central review to be contraindicated for LITT.
• The presence of uncontrolled leptomeningeal disease or extracranial disease including:
• Evidence of untreated obstructive hydrocephalus or mass effect causing \>10 millimeter (mm) midline shift
• Presence of symptomatic intratumoral hemorrhage (Grade 3 \& 4). Intratumoral hemorrhage grade 2 needs to be discussed with study team.
• Participants who are receiving any other investigational agents.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
• Important note: The eligibility criteria listed above are interpreted literally and cannot be waived.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Pacific Pediatric Neuro-Oncology Consortium: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sabine Mueller, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Margaret Shatara

  Children's Minnesota

  STUDY CHAIR

Central Study Contacts

PNOC Operations Office

CONTACT

415-502-1600; PNOC042@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: March 25, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)