Low-grade GliomaNCT07506239
Efficacy of Laser Interstitial Thermal Therapy in Young Persons With Low-grade Glioma
A study testing Laser Interstitial Thermal Therapy (LITT), Magnetic resonance imaging (MRI) and Questionnaires in people with Low-grade Glioma and Recurrent Low Grade Glioma, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Low-grade Glioma, Recurrent Low Grade Glioma, Low Grade Glioma of Brain
- What is being tested?
- Laser Interstitial Thermal Therapy (LITT), Magnetic resonance imaging (MRI) and Questionnaires
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2026to 1 Jan 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
PNOC Operations Office, 415-502-1600, PNOC042@ucsf.edu
877-827-3222, cancertrials@ucsf.edu
About this study
Official title: PNOC042: A Phase 2, Multi-institutional Trial, Evaluating the Efficacy of Laser Interstitial Thermal Therapy (LITT) in Children, Adolescents and Young Adults With Recurrent or Progressive Low-grade Gliomas (LGG)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To estimate the proportion of patients with recurrent or progressive LGGs who do not exhibit further disease progression at 15 months post-LITT.
EXPLORATORY OBJECTIVES:
- To determine the safety and describe the toxicity of LITT in children and young adults with recurrent or progressive LGGs according to the NCI CTCAE v6.0.
II. To estimate the duration of response (DOR) following LITT in children and young adults with recurrent or progressive LGGs.
III. To estimate the objective response rate (ORR) following LITT in children and young adults with recurrent or progressive LGGs.
IV. To estimate the time to next treatment following LITT in children and young adults with recurrent or progressive LGGs.
- To evaluate the potential effect of LITT on cystic tumors radiographically.
VI. To evaluate the impact of the extent of ablation on DOR, ORR, and PFS VII. To evaluate the impact of seizure frequency following LITT by using Engel classification and the International League Against Epilepsy (ILAE) outcome scale at 3 months, 1- and 2- years.
VIII. To evaluate the impact of ablation volume on the development of symptomatic post-ablation edema as indicated by the need to initiate treatment with Dexamethasone or bevacizumab for symptomatic edema within 60 days following the procedure.
OUTLINE: Participants receive Laser Interstitial Thermal Therapy (LITT) and are followed for 24 months from the day of LITT. Participants will then be transitioned to the PNOC COMP protocol and followed until death or withdrawal from study.
- Being tested
- Laser Interstitial Thermal Therapy (LITT), Magnetic resonance imaging (MRI), Questionnaires
- Keywords
- Interstitial Laser Therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Interstitial Thermal Therapy (LITT)Device
Also called LITT
Perform ablation using LITT
Magnetic resonance imaging (MRI)Procedure or surgery
Also called MRI
Undergo single imaging procedure
QuestionnairesOther
Participants will complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Laser Interstitial Thermal Therapy (LITT); Procedure: Magnetic resonance imaging (MRI); Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start25 Mar 2026
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-grade GliomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Pacific Pediatric Neuro-Oncology Consortium
- Responsible party
- Sponsor
- Investigators
- Sabine Mueller, MD, PhD, Principal investigator, University of California, San FranciscoMargaret Shatara, Study chair, Children's Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506239
- Sponsor's protocol ID
- 250828
- Other IDs
- NCI-2026-01278
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified datasets may be shared with research collaborators during the course of the study.