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TerminatedNCT02880410FLAGUpdated Apr 12, 2024

Feasibility Study on LITT for Newly Diagnosed Glioblastoma

A Phase 1 interventional study of NeuroBlate System and Radiation therapy and temozolomide in Glioblastoma, sponsored by Monteris Medical. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Monteris Medical · Phase 1, Interventional, and Treatment

Why this study was terminated
Terminated (failure to enroll)

From the registry’s dates

  • Primary completion was Sep 2018, 8 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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).

02

Conditions studied

  • Glioblastoma

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Keywords

  • Glioblastoma
  • NeuroBlate
  • LITT
  • Quality of Life
03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 3 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Monteris Medical is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • 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 · Drug: Radiation therapy and temozolomide

Interventions

  • DeviceNeuroBlate System

    Laser Interstitial Thermal Therapy

  • DrugRadiation therapy and temozolomide

    Radiation therapy and temozolomide

06

What researchers measure

Primary outcomes

  1. Adverse Events

    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.

    Time frame: 2 Years

Secondary outcomes

  1. Progression-Free Survival Rate

    To describe progression-free survival rate in subjects with newly diagnosed glioblastomas treated with the NeuroBlate System

    Time frame: 2 Years

  2. Overall Survival

    To describe/estimate the overall survival of subjects with newly diagnosed glioblastomas treated with LITT using the NeuroBlate System

    Time frame: 2 Years

  3. Changes in Quality of Life

    Characterize the changes in quality of life in subjects with newly diagnosed glioblastoma who are undergoing LITT using the NeuroBlate System via Quality of Life and neurocognitive assessment tools

    Time frame: 2 Years

07

Study locations

4 sites
  • Washington University
    Saint Louis, Missouri 63110, United States
  • Wake Forest Baptist Health
    Winston-Salem, North Carolina 27157, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02880410
Lead sponsor
Monteris Medical
Responsible party
Sponsor
First posted
Aug 26, 2016
Start date
Aug 15, 2017
Primary completion
Sep 14, 2018
Completion
Sep 14, 2018
Last update
Apr 12, 2024

Study contacts

Manmeet Ahluwalia, MD
principal investigator · The Cleveland Clinic
Sujit Prabhu, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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