Brain Tumor Clinical Trial
Official title:
LITT for the Treatment of Newly Diagnosed Central Nervous System Tumors Located in Difficult to Surgically Access Regions of the Brain and Recurrent/Resistant Pediatric Central Nervous System Tumors Located Anywhere Within the Brain
NCT number | NCT02451215 |
Other study ID # | 1504-044 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | January 1, 2020 |
Verified date | January 2020 |
Source | Children's Hospitals and Clinics of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | January 1, 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 22 Years |
Eligibility |
Inclusion Criteria: 1. Age between 1 and 22 years. 2. 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. 3. Tumor volume less than 10 cm3 is mandatory for high grade tumors. 4. 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. 5. 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). 6. 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: 1. Grade I or II glioma, 2. Desmoplastic neuroectodermal tumor (DNET), 3. Ganglioglioma, 4. Desmoplastic infantile ganglioglioma/astrocytoma, 5. Choroid plexus papilloma (CPP), 6. Meningioma, 7. Subependymal giant cell astrocytoma (SEGA), 8. Craniopharyngioma 9. Teratoma, or 10. 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: 1. Grade III or IV glioma, 2. Ependymoma, 3. Atypical teratoid rhabdoid tumor (ATRT), 4. Choroid plexus carcinoma (CPC), 5. Germ cell tumor (GCT), 6. Medulloblastoma/primitive neuroectodermal tumor (PNET), 7. Other "high grade CNS tumors". |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospitals and Clinics of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Children's Hospitals and Clinics of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Tumor control based on extent of tumor ablation | Each patient will undergo an MRI thermal map defining the volume of ablated tumor. This volume will be assessed to determine if it is a predictive factor for tumor recurrence or progression. | 10 or more years | |
Secondary | Characterization of the MRI changes following LITT tumor ablation | The MRI changes that occur following ablation of pediatric brain tumors will be characterized and compared with the MRI findings previously described in adult brain tumors following LITT therapy. | 10 years |
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