Efficacy of Laser Interstitial Thermal Therapy in Young Persons With Low-grade Glioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-25
SponsorUniversity of California, San Francisco
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Suprasellar gliomas not arising from the optic pathway are eligible.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Laser Interstitial Thermal Therapy (LITT)
DevicePerform ablation using LITT
Magnetic resonance imaging (MRI)
Procedure/SurgeryUndergo single imaging procedure
Questionnaires
Other interventionParticipants will complete questionnaires
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Experiment: Laser Interstitial Thermal Therapy (LITT)Experimental treatment 3 interventions
Trial outcomes
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.
Time frame
up to 15 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
Pacific Pediatric Neuro-Oncology Consortium
Collaborator
Source ClinicalTrials.gov