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

NCT02451215 | Completed DMC

• 1 other identifier: 1504-044
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Tumor

Outcome Measures

Primary Outcomes (2)

• Morbidity of LITT for the treatment of pediatric brain tumors

  The side-effects of LITT for the treatment of pediatric brain tumors will be monitored and compared with disease matched historical controls who underwent open craniotomy for resection or biopsy.

  10 years

• Efficacy of LITT for the treatment of pediatric brain tumors

  Rates of recurrence or progression of patients treated with LITT for the treatment of pediatric brain tumors will be compared with disease matched historical controls who underwent open craniotomy for resection or biopsy

  10 or more years

Secondary Outcomes (2)

• Tumor control based on extent of tumor ablation

  10 or more years

• Characterization of the MRI changes following LITT tumor ablation

  10 years

Study Arms (1)

Laser interstitial thermotherapy (LITT) treated patients

EXPERIMENTAL

All patients enrolled on the trial will undergo LITT therapy per protocol. Side-effects and outcomes will be monitored and compared with disease matched historical controls.

Device: Laser Interstitial Thermotherapy (LITT)

Interventions

Laser Interstitial Thermotherapy (LITT) DEVICE

Magnetic resonance imaging (MRI)-guided laser interstitial thermal therapy (LITT) is a minimally invasive surgical option to treat CNS tumors. LITT uses laser energy delivered to a target (i.e. CNS tumor) through a fiberoptic catheter, which results in damage to intracellular proteins and DNA, and subsequent cell death. LITT provides a sharp demarcation between ablated and unharmed tissue, which, when combined with the ability to monitor and control the ablation via MR thermal imaging, results in a high level of precision and control.

Also known as: Visualase, Neuroblate

Laser interstitial thermotherapy (LITT) treated patients

Eligibility Criteria

• Age: 1 Year - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Anne E Bendel, M.D.

  Children's Hospitals and Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Oncologist, Director of Neurooncology

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 21, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 23, 2020

Record last verified: 2020-01

Locations

US (1)