Brain NeoplasmsPhase 1NCT01012154
In Vivo Confocal Microscopy Tumor Atlas Study
A Phase 1 study testing Endomicroscope in people with Brain Neoplasms, run by Carl Zeiss Surgical GmbH at 1 site in United States.
Trial summary
This study aims to create an atlas based on the preliminary experience of the first feasibility study in neurosurgery. Hypothesis: That a confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables documentation of neurological pathology across a range of tumor ypes and grades… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- Endomicroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 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
- All patients with neurological pathology requiring surgery in which tumour resection might be evaluated by using biopsy
Who cannot join
- History of allergy to fluorescein
- Patients on beta-blockers or ACE inhibitors
- Pregnant women
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Peter Nakaji, MD contact
United States1 site, 1 recruiting
- Recruiting
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
Peter Nakaji, MD
Robert F Spetzler, MD
About this study
This study aims to create an atlas based on the preliminary experience of the first feasibility study in neurosurgery. Hypothesis: That a confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables documentation of neurological pathology across a range of tumor ypes and grades, suitable for comparison with traditional histopathology from site-matched biopsies.
Read the detailed description
Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. The procedure involves a small endoscope which is placed gently into contact with the tissue, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. It is already in clinical use in the field of gastroenterological endoscopy, and investigational use in laparoscopy, dermatology and gynecology. Further, in recent pilot studies endomicroscopy has also been shown to be feasible in bronchoscopy, robot assisted prostatectomy and neurosurgery.The study will use both endomicroscopy and biopsy to document the histological appearance of a range of neurological tumour types and grades.
In subsequent analysis, the confocal image data and corresponding histology data and images will be used to document reliably observable features in the confocal images that are relevant to histopathology interpretation. Relevant images will be selected and discussed by comparison to frozen or permanent section histology for compilation into an atlas documenting comparison for the tumors seen in the study.
- Conditions
- Brain Neoplasms
- Being tested
- Endomicroscope
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndomicroscopeDevice
Endomicroscopic images and biopsies are taken at several positions on the tumor.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Not described Receives: Device: Endomicroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of an atlas documenting the comparative features of in vivo microscopy versus traditional histopathology of site-matched biopsies across a range of tumor types and grades.
Measured: During surgery
Secondary outcomes (2)
Test the ability of an expert neuropathologist to predict the outcome of biopsies based on the confocal images collected in vivo.
Measured: One week
Capture usability and workflow aspects for the confocal device.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Surgical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter Nakaji, MD, Principal investigator, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012154
- Sponsor's protocol ID
- 002874
- Status last verified
- Nov 2009
- First submitted
- 10 Nov 2009
- Last updated
- 11 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Confocal Microscopy Tumor Atlas Study
- ClinicalTrials.gov ID
- NCT01012154
- Acronym / sponsor ID
- 002874
- Conditions
- Brain Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Carl Zeiss Surgical GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 11 Nov 2009 (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.
This study aims to create an atlas based on the preliminary experience of the first feasibility study in neurosurgery. Hypothesis: That a confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables documentation of neurological pathology across a range of tumor ypes and grades, suitable for comparison with traditional histopathology from site-matched biopsies.
Detailed description
Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. The procedure involves a small endoscope which is placed gently into contact with the tissue, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. It is already in clinical use in the field of gastroenterological endoscopy, and investigational use in laparoscopy, dermatology and gynecology. Further, in recent pilot studies endomicroscopy has also been shown to be feasible in bronchoscopy, robot assisted prostatectomy and neurosurgery.The study will use both endomicroscopy and biopsy to document the histological appearance of a range of neurological tumour types and grades.
In subsequent analysis, the confocal image data and corresponding histology data and images will be used to document reliably observable features in the confocal images that are relevant to histopathology interpretation. Relevant images will be selected and discussed by comparison to frozen or permanent section histology for compilation into an atlas documenting comparison for the tumors seen in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: Endomicroscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with neurological pathology requiring surgery in which tumour resection might be evaluated by using biopsy
Key exclusion criteria (4 listed)
- History of allergy to fluorescein
- Patients on beta-blockers or ACE inhibitors
- Pregnant women
- Inability to give informed consent
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 |
|---|---|---|
| EndomicroscopeEndomicroscopic images and biopsies are taken at several positions on the tumor. | Device | All patients |
Primary outcome
Generation of an atlas documenting the comparative features of in vivo microscopy versus traditional histopathology of site-matched biopsies across a range of tumor types and grades.
Time frame: During surgery
2 secondary outcomes
Test the ability of an expert neuropathologist to predict the outcome of biopsies based on the confocal images collected in vivo.
Time frame: One week
Capture usability and workflow aspects for the confocal device.
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2009.
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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.
Peter Nakaji, MD contact
Peter Nakaji, MD principal investigator
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Endomicroscope in people with Brain Neoplasms, run by Carl Zeiss Surgical GmbH at 1 site 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Nakaji, MD (602-406-4808), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generation of an atlas documenting the comparative features of in vivo microscopy versus traditional histopathology of site-matched biopsies across a range of tumor types and grades. (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Nov 2009.