Malignant GliomaLITTNCT01515085
MRI-Guided Laser Induced Thermal Therapy
An observational study of Malignant Glioma, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Does MR-guided laser interstitial thermal therapy (MRgLITT) prior to chemotherapy and/or radiation give patients a beneficial increase in overall survival? Laser induced thermal therapy (LITT) is a minimally invasive procedure for destroying tissue through generation of heat. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- laser interstitial thermal therapy
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jun 2012
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with brain tumors receiving MR-guided laser ablation
Who may be able to join
- Subjects that have/will undergo MRgLITT for inoperable brain tumor.
- Tumor size < 3cm in transverse diameter for each planned applicator placement.
- Tumor size < 4 cm in largest dimension.
- Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.
- Karnofsky Performance Scale score > 70.
- ECOG performance status of 2 or better.
- Biopsy proven histologic diagnosis of malignant glioma.
Who cannot join
- Patients with co-existing medical conditions with life expectancy < 1 year.
- Patients having received pre-ablation chemotherapy and/or radiation to lesion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
About this study
Official title: MRI-Guided Laser-Induced Thermal Therapy for Cytoreduction of Inoperable Grade III/IV GLiomas Prior to Chemotherapy and Radiation
Does MR-guided laser interstitial thermal therapy (MRgLITT) prior to chemotherapy and/or radiation give patients a beneficial increase in overall survival? Laser induced thermal therapy (LITT) is a minimally invasive procedure for destroying tissue through generation of heat.
Read the detailed description
Laser induced thermal therapy (LITT) is a procedure for destroying tissue through generation of heat. When used in conjunction with fiberoptic applicators, it offers an excellent means of minimally invasive surgery. As opposed to other thermal techniques like radio-frequency (RF) ablation, or cryo-ablation, LITT may be significantly faster and may exhibit sharper boundary of the thermal ablation zone. More importantly, LITT is highly compatible with MR imaging and when coupled with MR thermal imaging (MRTI) guidance, precise monitoring of the thermal ablation zone in order to avoid eloquent or critical structures is possible.
In this study, we propose to evaluate MR-thermal image guided laser interstitial therapy for the treatment of inoperable brain tumors as upfront therapy prior to initiation of chemotherapy and radiation. MR-thermal imaging (MRTI) will be used to provide information on thermal dose delivered to the target and be used to control laser delivery to prevent damage to critical structures.
- Conditions
- Malignant Glioma
- Being tested
- laser interstitial thermal therapy
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser interstitial thermal therapyProcedure or surgery
Also called laser ablation, LITT
residual gliomas either after debulking or biopsy evaluated for intervention with laser ablation prior to onset of adjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| biopsy proven glioma, no prior treatment | Not described Receives: Procedure: laser interstitial thermal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: three years
Secondary outcomes (1)
Overall survival
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: PI elected to close study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey
- Responsible party
- Sponsor
- Investigators
- Shabbar F Danish, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515085
- Sponsor's protocol ID
- 0220110114
- Acronym
- LITT
- Status last verified
- May 2014
- First submitted
- 18 Oct 2011
- Last updated
- 22 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-Guided Laser-Induced Thermal Therapy for Cytoreduction of Inoperable Grade III/IV GLiomas Prior to Chemotherapy and Radiation
- ClinicalTrials.gov ID
- NCT01515085
- Acronym / sponsor ID
- LITT / 0220110114
- Conditions
- Malignant Glioma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI elected to close study
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Jan 2012 (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.
Does MR-guided laser interstitial thermal therapy (MRgLITT) prior to chemotherapy and/or radiation give patients a beneficial increase in overall survival? Laser induced thermal therapy (LITT) is a minimally invasive procedure for destroying tissue through generation of heat.
Detailed description
Laser induced thermal therapy (LITT) is a procedure for destroying tissue through generation of heat. When used in conjunction with fiberoptic applicators, it offers an excellent means of minimally invasive surgery. As opposed to other thermal techniques like radio-frequency (RF) ablation, or cryo-ablation, LITT may be significantly faster and may exhibit sharper boundary of the thermal ablation zone. More importantly, LITT is highly compatible with MR imaging and when coupled with MR thermal imaging (MRTI) guidance, precise monitoring of the thermal ablation zone in order to avoid eloquent or critical structures is possible.
In this study, we propose to evaluate MR-thermal image guided laser interstitial therapy for the treatment of inoperable brain tumors as upfront therapy prior to initiation of chemotherapy and radiation. MR-thermal imaging (MRTI) will be used to provide information on thermal dose delivered to the target and be used to control laser delivery to prevent damage to critical structures.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biopsy proven glioma, no prior treatment | – | Procedure: laser interstitial thermal therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with brain tumors receiving MR-guided laser ablation
Key inclusion criteria (7 listed)
- Subjects that have/will undergo MRgLITT for inoperable brain tumor.
- Tumor size < 3cm in transverse diameter for each planned applicator placement.
- Tumor size < 4 cm in largest dimension.
- Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.
- Karnofsky Performance Scale score > 70.
Key exclusion criteria (2 listed)
- Patients with co-existing medical conditions with life expectancy < 1 year.
- Patients having received pre-ablation chemotherapy and/or radiation to lesion.
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 thermal therapyAlso: laser ablation, LITTresidual gliomas either after debulking or biopsy evaluated for intervention with laser ablation prior to onset of adjuvant therapy | Procedure or surgery | biopsy proven glioma, no prior treatment |
Primary outcome
Progression free survival
Time frame: three years
1 secondary outcome
Overall survival
Time frame: three years
Results and safety
The study was stopped early (reason given: PI elected to close study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2014.
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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.
Shabbar F Danish, MD principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Glioma, run by Rutgers, The State University of New Jersey 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 7 inclusion and 2 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: stopped early, as of the sponsor's last update on 22 May 2014. 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 was stopped early (reason given: PI elected to close study). Results are not available in the source record.
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?
Progression free survival (time frame: three years). 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 22 May 2014.