Clinical trial NCT02880410: Feasibility Study on LITT for Newly Diagnosed Glioblastoma
Official title: Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Glioblastoma
Keywords: Glioblastoma
NeuroBlate
LITT
Quality of Life
Lead sponsor: Monteris Medical
Sponsor class: INDUSTRY
First posted: 2016-08-26
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multicenter, open-label, prospective designed study to characterize the performance of brain laser interstitial thermal therapy (LITT) ablation using the Monteris NeuroBlate System in combination with standard of care radiation therapy and temozolomide for the treatment of newly diagnosed glioblastomas (GBM).


Eligibility criteria: Relevant Inclusion Criteria:

1. Biopsy proven supratentorial GBM that has not undergone previous surgical resection, radiation and/or chemotherapy
2. Single enhancing lesion that is \>1 cm, but \< 4 cm in cross-sectional dimension, including thalamic tumor (≤ 3 cm)
3. The patient must be ≥18 years of age
4. KPS \> 70
5. Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder. Patients with prior malignancies must be disease-free for five years.
6. Stable cardiovascular, pulmonary health status

Relevant Exclusion Criteria:

1. Seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs
2. Symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ≥5mm midline shift significant
3. Uncontrolled cardiovascular conditions of hypertension (systolic \>180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage
4. Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements
5. Pregnancy, or planning to become pregnant
6. Patients whose physical dimensions cannot be accommodated in the MRI scanner or patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel and other internal ferromagnetic objects
7. Patients with multiple or multifocal GBM

Primary outcomes:
measure: Adverse Events
timeFrame: 2 Years
Secondary outcomes:
measure: Progression-Free Survival Rate
timeFrame: 2 Years
measure: Overall Survival
timeFrame: 2 Years
measure: Changes in Quality of Life
timeFrame: 2 Years
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: The Cleveland Clinic
name: Manmeet Ahluwalia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Sujit Prabhu, MD
role: PRINCIPAL_INVESTIGATOR
References: