NCT02880410

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
Last Updated

April 12, 2024

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

August 18, 2016

Last Update Submit

April 11, 2024

Conditions

Glioblastoma

Keywords

GlioblastomaNeuroBlateLITTQuality of Life

Outcome Measures

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.

    2 Years

Secondary Outcomes (3)

  • Progression-Free Survival Rate

    2 Years

  • Overall Survival

    2 Years

  • Changes in Quality of Life

    2 Years

Study Arms (1)

LITT Treatment w/radiation therapy and temozolomide

EXPERIMENTAL

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 SystemDrug: Radiation therapy and temozolomide

Interventions

NeuroBlate SystemDEVICE

Laser Interstitial Thermal Therapy

LITT Treatment w/radiation therapy and temozolomide
Radiation therapy and temozolomideDRUG

Radiation therapy and temozolomide

LITT Treatment w/radiation therapy and temozolomide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven supratentorial GBM that has not undergone previous surgical resection, radiation and/or chemotherapy
  • Single enhancing lesion that is \>1 cm, but \< 4 cm in cross-sectional dimension, including thalamic tumor (≤ 3 cm)
  • The patient must be ≥18 years of age
  • KPS \> 70
  • 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.
  • Stable cardiovascular, pulmonary health status

You may not qualify if:

  • Seizures occurrence or the requirement of escalation (or addition) of anti-epileptic drugs
  • Symptoms due to mass effect of the tumor including high intracranial pressure, marked edema or ≥5mm midline shift significant
  • Uncontrolled cardiovascular conditions of hypertension (systolic \>180 mm Hg), angina pectoris, or cardiac dysrhythmia; or recent history of intracranial hemorrhage
  • Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements
  • Pregnancy, or planning to become pregnant
  • 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
  • Patients with multiple or multifocal GBM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Washington University

St Louis, Missouri, 63110, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

RadiotherapyTemozolomide

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

TherapeuticsDacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Manmeet Ahluwalia, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Sujit Prabhu, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2016

First Posted

August 26, 2016

Study Start

August 15, 2017

Primary Completion

September 14, 2018

Study Completion

September 14, 2018

Last Updated

April 12, 2024

Record last verified: 2021-08

Locations

US(4)