Laser Interstitial Thermal Therapy (LITT) for the Treatment of Pediatric Central Nervous System Tumors

Completed · Not applicable

Conditions studied: Brain Tumor

In brief

Laser Interstitial Thermal Therapy (LITT) is a minimally invasive surgical technique that allows for biopsy and thermal ablation of brain tumors. Pediatric patients with brain tumors who are eligible and enroll in the trial will undergo LITT at the time of diagnosis or at the time of recurrence/progression rather than undergo an open craniotomy and tumor resection/biopsy. LITT will include a stereotactic biopsy followed by thermal ablation of the tumor. This study will monitor the safety and efficacy of LITT for the treatment of pediatric brain tumors.

Key facts

Study ID

NCT02451215

Run by

Children's Hospitals and Clinics of Minnesota

People needed

10

Starts

2015-04-01

Expected to finish

2020-01-01

Last updated by the study team

2020-01-23

Who can join

Age: 1 and older, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 1 and 22 years.
• Karnofsky Performance Scale (for patients > 12 y/o) or Lansky Performance Score (for patients < 12y/o) must be > 50 assessed within two-weeks prior to enrollment.
• Tumor volume less than 10 cm3 is mandatory for high grade tumors.
• Tumor volume greater than 10 cm3 is acceptable in low grade tumors if the entire tumor can be ablated in more than one staged procedure.
• Histology must be available, obtained either at a prior surgery or at the time of LITT by stereotactic biopsy (except in germ cell tumors where elevation of tumor markers is diagnostic).
• Patients must meet the following histological and disease states:
• A) Newly diagnosed low-grade CNS tumor located in a site that is difficult to access surgically or recurrent/persistent low-grade CNS tumor (any site) despite treatment with conventional therapy. Tumor types include:
• Grade I or II glioma,
• Desmoplastic neuroectodermal tumor (DNET),
• Ganglioglioma,
• Desmoplastic infantile ganglioglioma/astrocytoma,
• Choroid plexus papilloma (CPP),
• Meningioma,
• Subependymal giant cell astrocytoma (SEGA),
• Craniopharyngioma
• Teratoma, or
• Other "low-grade CNS tumors"
• B) Newly diagnosed high-grade CNS tumor located in a site that is difficult to access surgically or recurrent/persistent high-grade CNS tumors (any site) despite treatment with conventional therapy. Tumor types include:
• Grade III or IV glioma,
• Ependymoma,
• Atypical teratoid rhabdoid tumor (ATRT),
• Choroid plexus carcinoma (CPC),
• Germ cell tumor (GCT),
• Medulloblastoma/primitive neuroectodermal tumor (PNET),
• Other "high grade CNS tumors".

Where it is running

• Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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