Loading clinical trials...

Feasibility Study on LITT for Newly Diagnosed Glioblastoma | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Feasibility Study on LITT for Newly Diagnosed Glioblastoma

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

NCT02880410•Monteris Medical

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Locations (4)

Washington University

St Louis, Missouri, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

MD Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

August 15, 2017

Primary Completion Date

September 14, 2018

Completion Date

September 14, 2018

Last Updated

April 12, 2024

Enrollment

ACTUAL participants

Conditions

Glioblastoma

Interventions

NeuroBlate System

DEVICE

Radiation therapy and temozolomide

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

RECRUITINGPHASE1

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

NCT06860594

Astrocytoma, IDH-Mutant, Grade 2Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Feasibility Study on LITT for Newly Diagnosed Glioblastoma

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma

Study of TLX101-Tx Plus Standard of Care (SoC) Versus SoC Alone for the Treatment of Patients With Recurrent Glioblastoma