Brain TumorNCT02451215
Laser Interstitial Thermal Therapy (LITT) for the Treatment of Pediatric Central Nervous System Tumors
A study testing Laser Interstitial Thermotherapy (LITT) in people with Brain Tumor, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 22 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Laser Interstitial Thermotherapy (LITT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
Show all 25Show fewer
- 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"
- 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".
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
About this study
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
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.
Read the 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:
- 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.
- Examine the role of LITT in controlling newly diagnosed difficult to surgically access CNS tumors or resistant/recurrent pediatric CNS tumors in any location.
- Assess the correlation between the extent of tumor ablation and the rate of local tumor control.
- 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.
- Conditions
- Brain Tumor
- Being tested
- Laser Interstitial Thermotherapy (LITT)
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Interstitial Thermotherapy (LITT)Device
Also called Visualase, Neuroblate
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Laser Interstitial Thermotherapy (LITT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 10 or more years
Secondary outcomes (2)
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.
Measured: 10 or more years
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startApr 2015
- Primary completionJan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Bendel, Children's Hospitals and Clinics of Minnesota
- Investigators
- Anne E Bendel, M.D., Principal investigator, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451215
- Sponsor's protocol ID
- 1504-044
- Status last verified
- Jan 2020
- First submitted
- 19 May 2015
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02451215
- Acronym / sponsor ID
- 1504-044
- Conditions
- Brain Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Examine the role of LITT in controlling newly diagnosed difficult to surgically access CNS tumors or resistant/recurrent pediatric CNS tumors in any location.
- Assess the correlation between the extent of tumor ablation and the rate of local tumor control.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser interstitial thermotherapy (LITT) treated patients | Experimental | Device: Laser Interstitial Thermotherapy (LITT)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. |
Who may qualify
- Ages
- 1 year to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (25 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Interstitial Thermotherapy (LITT)Also: Visualase, NeuroblateMagnetic 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. | Device | Laser interstitial thermotherapy (LITT) treated patients |
Primary outcome
Morbidity of LITT for the treatment of pediatric brain tumors
Time frame: 10 years
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.
Efficacy of LITT for the treatment of pediatric brain tumors
Time frame: 10 or more years
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
2 secondary outcomes
Tumor control based on extent of tumor ablation
Time frame: 10 or more years
Characterization of the MRI changes following LITT tumor ablation
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
Related trials for Brain Tumor
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Recruiting
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Pediatric Brain Tumor
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Recruiting
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Cancer-related Cognitive Dysfunction, Primary Brain Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne E Bendel, M.D. principal investigator
Children's Hospitals and Clinics of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Interstitial Thermotherapy (LITT) in people with Brain Tumor, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity of LITT for the treatment of pediatric brain tumors (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.