Back to resultsMonteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors
Primary Purpose
Brain Tumor, Brain Tumor, Recurrent, Brain Neoplasm
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AutoLITT system
Sponsored by
About this trial
This is an interventional treatment trial for Brain Tumor focused on measuring laser interstitial thermal therapy, laser therapy, thermal therapy, brain tumors, recurrent brain tumor, progressive brain tumor, glioblastoma multiforme tumor
Eligibility Criteria
Inclusion Criteria:
- Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy
- Clinical/radiographic suspicion of tumor recurrence/progression
Exclusion Criteria:
- Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).
Sites / Locations
- University Hospitals Cleveland Medical Center
- Cleveland Clinic Foundation, 9500 Euclid Ave
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Active Arm
Arm Description
Only Arm. Patients treated using AutoLITT System.
Outcomes
Primary Outcome Measures
Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00747253
Brief Title
Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors
Official Title
AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Monteris Medical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The main purpose of this study is to evaluate the safety and performance of the AutoLITT system for the treatment of recurrent/progressive glioblastoma multiforme tumors (GBM).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Brain Tumor, Recurrent, Brain Neoplasm, Brain Cancer, Glioblastoma Multiforme, Recurrent Glioblastoma Multiforme
Keywords
laser interstitial thermal therapy, laser therapy, thermal therapy, brain tumors, recurrent brain tumor, progressive brain tumor, glioblastoma multiforme tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Active Arm
Arm Type
Experimental
Arm Description
Only Arm. Patients treated using AutoLITT System.
Intervention Type
Device
Intervention Name(s)
AutoLITT system
Intervention Description
laser treatment with the AutoLITT system
Primary Outcome Measure Information:
Title
Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits
Time Frame
14 days post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy
Clinical/radiographic suspicion of tumor recurrence/progression
Exclusion Criteria:
Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gene Barnett, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Sloan, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation, 9500 Euclid Ave
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23560574
Citation
Sloan AE, Ahluwalia MS, Valerio-Pascua J, Manjila S, Torchia MG, Jones SE, Sunshine JL, Phillips M, Griswold MA, Clampitt M, Brewer C, Jochum J, McGraw MV, Diorio D, Ditz G, Barnett GH. Results of the NeuroBlate System first-in-humans Phase I clinical trial for recurrent glioblastoma: clinical article. J Neurosurg. 2013 Jun;118(6):1202-19. doi: 10.3171/2013.1.JNS1291. Epub 2013 Apr 5.
Results Reference
derived
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Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors
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