Feasibility Study on LITT for Newly Diagnosed Glioblastoma (FLAG)

Monteris Medical

Status and phase: Terminated; Phase 1

Conditions: Glioblastoma

Treatments: Device: NeuroBlate System; Drug: Radiation therapy and temozolomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02880410

FLAG

Details and patient eligibility

About

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).

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

LITT Treatment w/radiation therapy and temozolomide

Experimental group

Description:

This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide

Treatment:

Drug: Radiation therapy and temozolomide

Device: NeuroBlate System