Laser Interstitial Thermal Therapy (LITT) for the Treatment of Pediatric Central Nervous System Tumors
Condition: Brain Tumor
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      Pediatric brain tumors have a variety of surgical options depending on the location and type
      of tumor. Complete or near complete surgical removal of pediatric brain tumors usually
      results in the best chance of survival or long-term control of the tumor. Surgical resection
      through an open craniotomy is the most common surgical treatment for accessible brain tumors.
      For tumors that are not surgically accessible or that are resistant to surgical intervention,
      treatment is limited to radiation and or chemotherapy, which can have significant long term
      toxicity in children.

      Laser interstitial thermal therapy (LITT) offers a minimally invasive surgical option to
      treat central nervous system (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. LITT may offer a
      treatment option for patients with deep brain lesions that are surgically inaccessible, such
      as tumors located in the thalamus, hypothalamus, basal ganglia and brainstem. LITT may also
      be a potential treatment for brain tumors which have recurred or persist despite conventional
      therapies including craniotomy. The MRI-guided laser probe used in LITT utilizes a much
      smaller surgical corridor through the brain to reach a deep lesion, potentially reducing the
      risk of complications.

      This study will offer LITT, rather than open craniotomy, for the diagnosis and treatment of
      newly diagnosed pediatric brain tumors located in difficult to surgically access regions of
      the brain and for the treatment of recurrent/resistant pediatric brain tumors located
      anywhere within the brain. The primary aim of this study is to determine if LITT is effective
      in reducing (or at least maintaining current rates of) tumor re-growth while lowering rates
      of post-surgical complications and improving quality of the procedure (i.e. shorter
      hospitalization and less use of pain medication compared to standard surgery for tumor
      removal/biopsy).

      This study has the following goals:

        1. Determine the frequency of post-operative side-effects in pediatric patients with newly
           diagnosed, difficult to surgically access CNS tumors or resistant/recurrent CNS tumors
           in any location who receive LITT treatment for tumor ablation.

        2. Examine the role of LITT in controlling newly diagnosed difficult to surgically access
           CNS tumors or resistant/recurrent pediatric CNS tumors in any location.

        3. Assess the correlation between the extent of tumor ablation and the rate of local tumor
           control.

        4. Characterize the MRI changes that occur in a pediatric tumor following LITT ablation.

      Patients enrolled on this study will require routine post-LITT follow-up, including
      intermittent physical exams to assess for side effects and MRIs to monitor the status of the
      tumor. The follow-up is similar to that performed following an open craniotomy and does not
      involve any extra studies. The side effects and rate of tumor control for each brain tumor
      patient enrolled on the trial will be compared to disease matched historical controls to
      learn more about the morbidity and efficacy of LITT in this population of patients compared
      to patients who underwent open craniotomy for resection/biopsy.
    

Intervention name(s): Laser Interstitial Thermotherapy (LITT)
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Visualase; Neuroblate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment