Brain TumorPhase 1NCT00747253
Monteris AutoLITT™ FIM Safety Trial for Recurrent/Progressive Brain Tumors
A Phase 1 study testing AutoLITT system in people with Brain Tumor and Brain Tumor, Recurrent, run by Monteris Medical at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Brain Tumor, Recurrent, Brain Neoplasm
- What is being tested?
- AutoLITT system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy
- Clinical/radiographic suspicion of tumor recurrence/progression
Who cannot join
- Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic Foundation, 9500 Euclid Ave
Cleveland, Ohio, 44195
About this study
Official title: AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors
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).
- Conditions
- Brain Tumor, Brain Tumor, Recurrent, Brain Neoplasm, Brain Cancer, Glioblastoma Multiforme, Recurrent Glioblastoma Multiforme
- Being tested
- AutoLITT system
- Keywords
- laser interstitial thermal therapy, laser therapy, thermal therapy, brain tumors, recurrent brain tumor, progressive brain tumor, glioblastoma multiforme tumor
- Medical subject headings
- Brain Neoplasms, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoLITT systemDevice
laser treatment with the AutoLITT system
| Study group | Role | What they receive |
|---|---|---|
| Single Active Arm | Experimental | Only Arm. Patients treated using AutoLITT System. Receives: Device: AutoLITT system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits
Measured: 14 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monteris Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gene Barnett, MD, Principal investigator, The Cleveland ClinicAndrew Sloan, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747253
- Sponsor's protocol ID
- AutoLITT™ FIM
- Status last verified
- Aug 2021
- First submitted
- 2 Sep 2008
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23560574
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AutoLITT™ FIM Trial - A Prospective First-In-Man (FIM) Safety Trial of the AutoLITT Laser Treatment of Recurrent/Progressive Brain Tumors
- ClinicalTrials.gov ID
- NCT00747253
- Acronym / sponsor ID
- AutoLITT™ FIM
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Monteris MedicalIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Active Arm | Experimental | Device: AutoLITT systemOnly Arm. Patients treated using AutoLITT System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous diagnosis of GBM treated with radiotherapy with or without surgical resection and/or chemotherapy
- Clinical/radiographic suspicion of tumor recurrence/progression
Key exclusion criteria (1 listed)
- Previous treatment of target GBM with stereotactic radiosurgery, brachytherapy, or carmustine impregnated wafers (Gliadel).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AutoLITT systemlaser treatment with the AutoLITT system | Device | Single Active Arm |
Primary outcome
Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits
Time frame: 14 days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Derived from this study: PubMed 23560574Sloan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gene Barnett, MD principal investigator
The Cleveland Clinic
Andrew Sloan, MD principal investigator
University Hospitals Cleveland Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AutoLITT system in people with Brain Tumor and Brain Tumor, Recurrent, run by Monteris Medical at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint is safety, as determined by absence of severe clinical toxicity or procedure-related neurological deficits (time frame: 14 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00747253, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.