Cerebral TumorsCleopatraNCT02491827
Confocal Laser Endomicroscopy (CLE) During Medically Induced Neurosurgery in Craniobasal and Glioma Tumours
An observational study of Cerebral Tumors, run by Charalampaki, Cleopatra, M.D. at 1 site in Germany.
Trial summary
Purpose of the study is to answer the question whether confocal laser endomicroscopy (CLE, also named 'optical biopsy') might improve the results of medically necessary neurosurgery to prove practicability, safety and harmlessness of CLE during neurosurgical procedures Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Tumors
- What is being tested?
- Cellvizio mini laser probe
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to 3 Aug 2016
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients suffering from either subcranial Tumors or cerebral gliomata
Who may be able to join
- patients administered to the department of neurosurgery requiring neurosurgery due to either diagnosed gliomata (40 patients) or diagnosed subcranial tumors adjacent to or already invading neuronal structures (20 patients)
- patients having given informed consent
Who cannot join
- severe concomitant diseases probably negatively influencing the participation in this clinical trial
- cardial infarction or stroke within the preceding 12 months
- Treatment resistant hypertonus (systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg or a combination of both
- Pulmonic diseases that might result in an advanced risk for anesthetic measurements
- Patients being vaccinated with live vaccines (14 days Prior) or contra Influenza (7 days Prior) to start of the study
- All concomitant findings that might increase in the eyes of the investigator the risk of participation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic of Neurosurgery, Hospital of Cologne
Cologne-Merheim, North Rhine Westfalia, 51109
About this study
Official title: Adjoint Intra-operative Confocal Laser Endomicroscopy (CLE) to Present Tissue on the Cellular Level in Defined Lesions of the Central Nervous System (CNS) During Medically Induced Neurosurgery in Subcranial Tumors and Glioma
Purpose of the study is to answer the question whether confocal laser endomicroscopy (CLE, also named 'optical biopsy') might improve the results of medically necessary neurosurgery to prove practicability, safety and harmlessness of CLE during neurosurgical procedures
Read the detailed description
In patients requiring neurosurgical oncological Intervention using endoscopic devices, a mini laser probe will be administered through the endoscopic device to characterize in vivo the tissue by thousandfold magnification down to the cellular level (so-called optical biopsy). Magnification is presented to the neurosurgeon in time to better differentiate between healthy and pathological tissue. Post-surgery results of in-vivo Differentiation will then be compared to histocytopathological findings.
- Conditions
- Cerebral Tumors
- Being tested
- Cellvizio mini laser probe
- Keywords
- optical biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellvizio mini laser probeOther
Cellvizio mini laser probe is administered via the endoscopic device used during the neurosurgical procedures to provide the optical biopsy
| Study group | Role | What they receive |
|---|---|---|
| Cellvizio mini laser probe | Cellvizio mini laser probe will be administered via the endoscopic device used for the neurosurgical procedure to provide confocal laser endomicroscopy in patients requiring neurosurgery due to glioma multiforme or subcranial tumors Receives: Other: Cellvizio mini laser probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology
Measured: duration of hospital stay, an expected average of 7 days
Secondary outcomes (3)
proof of complete removal of pathologic tissue within healthy tissue
Measured: during surgical procedure, an expected average time of three hours
optimal tumour remission or reduction after 3 months post-surgery proven by respective diagnostic measurements
Measured: 3 months post surgery
Composite measure of missing iatrogenic damage of healthy neuronal structures and preservation of functionality of healthy tissue
Measured: individual post-surgery controls, an expected average of up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startDec 2015
- Primary completion3 Aug 2016
- Study completion3 Aug 2016
Why it stopped: Study stopped by local authorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral TumorsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charalampaki, Cleopatra, M.D.
- Responsible party
- Sponsor
- Investigators
- Cleopatra Charalampaki, MD Prof, Principal investigator, Department Neurosurgery, Hospital Koeln-Merheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491827
- Sponsor's protocol ID
- CLE 001
- Acronym
- Cleopatra
- Status last verified
- Feb 2019
- First submitted
- 1 Jul 2015
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjoint Intra-operative Confocal Laser Endomicroscopy (CLE) to Present Tissue on the Cellular Level in Defined Lesions of the Central Nervous System (CNS) During Medically Induced Neurosurgery in Subcranial Tumors and Glioma
- ClinicalTrials.gov ID
- NCT02491827
- Acronym / sponsor ID
- Cleopatra / CLE 001
- Conditions
- Cerebral Tumors
- Keywords
- optical biopsy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study stopped by local authorities
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Charalampaki, Cleopatra, M.D.
- Study start
- Dec 2015
- Primary completion
- 3 Aug 2016 (actual)
- Study completion
- 3 Aug 2016 (actual)
- First posted
- 8 Jul 2015 (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.
Purpose of the study is to answer the question whether confocal laser endomicroscopy (CLE, also named 'optical biopsy') might improve the results of medically necessary neurosurgery to prove practicability, safety and harmlessness of CLE during neurosurgical procedures
Detailed description
In patients requiring neurosurgical oncological Intervention using endoscopic devices, a mini laser probe will be administered through the endoscopic device to characterize in vivo the tissue by thousandfold magnification down to the cellular level (so-called optical biopsy). Magnification is presented to the neurosurgeon in time to better differentiate between healthy and pathological tissue. Post-surgery results of in-vivo Differentiation will then be compared to histocytopathological findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cellvizio mini laser probe | – | Other: Cellvizio mini laser probeCellvizio mini laser probe will be administered via the endoscopic device used for the neurosurgical procedure to provide confocal laser endomicroscopy in patients requiring neurosurgery due to glioma multiforme or subcranial tumors |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients suffering from either subcranial Tumors or cerebral gliomata
Key inclusion criteria (2 listed)
- patients administered to the department of neurosurgery requiring neurosurgery due to either diagnosed gliomata (40 patients) or diagnosed subcranial tumors adjacent to or already invading neuronal structures (20 patients)
- patients having given informed consent
Key exclusion criteria (6 listed)
- severe concomitant diseases probably negatively influencing the participation in this clinical trial
- cardial infarction or stroke within the preceding 12 months
- Treatment resistant hypertonus (systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg or a combination of both
- Pulmonic diseases that might result in an advanced risk for anesthetic measurements
- Patients being vaccinated with live vaccines (14 days Prior) or contra Influenza (7 days Prior) to start of the study
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 |
|---|---|---|
| Cellvizio mini laser probeCellvizio mini laser probe is administered via the endoscopic device used during the neurosurgical procedures to provide the optical biopsy | Other | Cellvizio mini laser probe |
Primary outcome
post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology
Time frame: duration of hospital stay, an expected average of 7 days
3 secondary outcomes
proof of complete removal of pathologic tissue within healthy tissue
Time frame: during surgical procedure, an expected average time of three hours
optimal tumour remission or reduction after 3 months post-surgery proven by respective diagnostic measurements
Time frame: 3 months post surgery
Composite measure of missing iatrogenic damage of healthy neuronal structures and preservation of functionality of healthy tissue
Time frame: individual post-surgery controls, an expected average of up to 7 days
Results and safety
The study was stopped early (reason given: Study stopped by local authorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Cleopatra Charalampaki, MD Prof principal investigator
Department Neurosurgery, Hospital Koeln-Merheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Tumors, run by Charalampaki, Cleopatra, M.D. at 1 site in Germany.
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 6 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: stopped early, as of the sponsor's last update on 6 Feb 2019. 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 Germany. 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.
Are results available for this study?
The study was stopped early (reason given: Study stopped by local authorities). Results are not available in the source record.
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?
post-surgery comparison of in-vivo tissue characterization with ex-vivo histocytopathology (time frame: duration of hospital stay, an expected average of 7 days). 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 6 Feb 2019.