Feasibility Study on LITT for Newly Diagnosed Glioblastoma



Status:Active, not recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 15, 2017
End Date:December 2020

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Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma

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).


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
We found this trial at
4
sites
Winston-Salem, North Carolina 27157
Principal Investigator: Roy Strowd, MD
Phone: 336-716-3842
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Winston-Salem, NC
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Alireza Mohammadi, MD
Phone: 216-444-6459
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Houston, Texas 77030
Principal Investigator: Barbara O'Brien
Phone: 713-745-5769
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Houston, TX
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Saint Louis, Missouri 63110
Principal Investigator: Albert Kim, MD
Phone: 314-362-2940
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Saint Louis, MO
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