Recruiting

LITT

Sponsor:

UCLA

Code:

NCT07506239

Conditions

Low-grade Glioma

Recurrent Low Grade Glioma

Low Grade Glioma of Brain

Pediatric Cancer

Eligibility Criteria

Sex: All

Age: 2 - 25

Healthy Volunteers: Not accepted

Interventions

Laser Interstitial Thermal Therapy (LITT)

Magnetic resonance imaging (MRI)

Questionnaires

Study Details

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

Study ID

NCT07506239

Start date

Mar 25, 2026

Status verified date

Mar, 2026

Completion date

Jan 1, 2031

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

  • Had their last fraction of local irradiation or focal radiosurgery to primary tumor ≥12 weeks prior to registration.
  • Had their last fraction of craniospinal irradiation or total body irradiation ≥ 12 weeks prior to registration

  • Age >= 2 years to <= 25 years of age
  • Performance Score: Karnofsky ≥ 50 for participants > 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
  • Corticosteroids: Participants who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration.
  • Patients must be surgically eligible per institutional standards.
  • Patients must co-enroll to Pediatric Neuro-oncology Consortium (PNOC) COMP if PNOC COMP is open to accrual at the enrolling institution.
  • A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experiment: Laser Interstitial Thermal Therapy (LITT)

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.

Interventions

Laser Interstitial Thermal Therapy (LITT)

Perform ablation using LITT

Magnetic resonance imaging (MRI)

Undergo single imaging procedure

Questionnaires

Participants will complete questionnaires

Primary outcome measure

  • Proportion of participants with Progression-free Survival (PFS) [ Time Frame: up to 15 months ]

Central Contacts and Locations

Central contacts

PNOC Operations Office

415-502-1600PNOC042@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Sabine Mueller, MD, PhD

More Information

Sponsor

University of California, San Francisco

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • Interstitial Laser Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-04-01.