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Trial record 2 of 7 for:    monteris

Feasibility Study on LITT for Newly Diagnosed Glioblastoma (FLAG)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2016 by Monteris Medical
Sponsor:
Information provided by (Responsible Party):
Monteris Medical
ClinicalTrials.gov Identifier:
NCT02880410
First received: August 18, 2016
Last updated: August 25, 2016
Last verified: August 2016
  Purpose
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).

Condition Intervention Phase
Glioblastoma
Device: NeuroBlate System
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility Study on Laser Interstitial Thermal Therapy Ablation for the Treatment of Newly Diagnosed Glioblastoma

Resource links provided by NLM:


Further study details as provided by Monteris Medical:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: 2 Years ]
    Characterize adverse events experienced in glioblastoma subjects undergoing LITT using the NeuroBlate System. Adverse events will be collected based on subject reports and subject examination/testing.


Secondary Outcome Measures:
  • Progression-Free Survival Rate [ Time Frame: 2 Years ]
    To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System

  • Overall Survival [ Time Frame: 2 Years ]
    To describe/estimate the overall survival of subjects with newly diagnosed glioblastomas treated with LITT using the NeuroBlate System

  • Changes in Quality of Life [ Time Frame: 2 Years ]
    Characterize the changes in quality of life in subjects with medical temporal lobe epilepsy undergoing LITT using the NeuroBlate System via Quality of Life and neurocognitive assessment tools


Estimated Enrollment: 45
Study Start Date: November 2016
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LITT Treatment w/radiation therapy and temozolomide
This is a single arm study. All eligible study subjects will undergo LITT with the NeuroBlate System in combination with radiation therapy and temozolomide
Device: NeuroBlate System
Laser Interstitial Thermal Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02880410

Contacts
Contact: Pa Lee plee@monteris.com
Contact: Audrey Singh asingh@monteris.com

Sponsors and Collaborators
Monteris Medical
  More Information

Responsible Party: Monteris Medical
ClinicalTrials.gov Identifier: NCT02880410     History of Changes
Other Study ID Numbers: FLAG 
Study First Received: August 18, 2016
Last Updated: August 25, 2016

Keywords provided by Monteris Medical:
Glioblastoma
NeuroBlate
LITT
Quality of Life

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on February 20, 2017