Cerebral Primitive Tumor With Chirurgical IndicationPhase 1CONDUCTOMENCT02077504
Glial Tumors Electromagnetic Signature Study by MagnetoEncephaloGraphy (MEG) "CONDUCTOME"
A Phase 1 study testing MEG and MRI in people with Cerebral Primitive Tumor With Chirurgical Indication, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The purpose of this study is to determine the correlation between functional MEG analysis of the tumor and its periphery and the tumor stage and treatment response. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Primitive Tumor With Chirurgical Indication
- What is being tested?
- MEG and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to 5 Jan 2018
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- more or equal than 18 years old
- patient affiliated to social security or similarly regime
- informed consent form signed
- supra-tentorial primitive cerebral tumor
Who cannot join
- Pregnant women and lactating mothers
- Ward of court or under guardianship
- Adult unable to express their consent
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their consent
- Person under legal protection
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- Magnetic Resonance Imaging (MRI) contraindication (implanted material non MRI-compatible, ferro-magnetic foreign body, claustrophobia)
- Patients needed emergency medical care for other pathology
- severely altered general health (Performance Status 3 or 4)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetoencephalographic Study of Glial Tumors Electromagnetic Signature
The purpose of this study is to determine the correlation between functional MEG analysis of the tumor and its periphery and the tumor stage and treatment response.
Read the detailed description
A better tumor grade definition would provide an optimized surgical care, prognosis and therapeutical response evaluation.
- Being tested
- MEG and MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEG and MRIOther
CONDUCTOME
| Study group | Role | What they receive |
|---|---|---|
| CONDUCTOME | Experimental | MEG and MRI Receives: Other: MEG and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) data in tumor grade prediction
Measured: 1 week before exeresis
anatomopathologic and clinical data in tumor grade prediction
Measured: 1 week after exeresis
Secondary outcomes (2)
Measurement of molecules involved in glial cells neuralisation expression in tumor samples
Measured: Up to 1 month after surgery
Tumoral growth modelisation from patient MEG and MRI data
Measured: Up to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startSep 2013
- Primary completion5 Jan 2018
- Study completion5 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Primitive Tumor With Chirurgical IndicationStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François BERGER, MD, PhD, Principal investigator, University Grenoble Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077504
- Sponsor's protocol ID
- CONDUCTOME
- Acronym
- CONDUCTOME
- Status last verified
- May 2018
- First submitted
- 18 Sep 2013
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetoencephalographic Study of Glial Tumors Electromagnetic Signature
- ClinicalTrials.gov ID
- NCT02077504
- Acronym / sponsor ID
- CONDUCTOME / CONDUCTOME
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 5 Jan 2018 (actual)
- First posted
- 4 Mar 2014 (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 purpose of this study is to determine the correlation between functional MEG analysis of the tumor and its periphery and the tumor stage and treatment response.
Detailed description
A better tumor grade definition would provide an optimized surgical care, prognosis and therapeutical response evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CONDUCTOME | Experimental | Other: MEG and MRIMEG and MRI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- more or equal than 18 years old
- patient affiliated to social security or similarly regime
- informed consent form signed
- supra-tentorial primitive cerebral tumor
Key exclusion criteria (9 listed)
- Pregnant women and lactating mothers
- Ward of court or under guardianship
- Adult unable to express their consent
- Person deprived of freedom by judicial or administrative decision
- Person hospitalized without their 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 |
|---|---|---|
| MEG and MRICONDUCTOME | Other | CONDUCTOME |
Primary outcome
Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) data in tumor grade prediction
Time frame: 1 week before exeresis
anatomopathologic and clinical data in tumor grade prediction
Time frame: 1 week after exeresis
2 secondary outcomes
Measurement of molecules involved in glial cells neuralisation expression in tumor samples
Time frame: Up to 1 month after surgery
Tumoral growth modelisation from patient MEG and MRI data
Time frame: Up to 1 month after surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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.
François BERGER, MD, PhD principal investigator
University Grenoble Hospital
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 MEG and MRI in people with Cerebral Primitive Tumor With Chirurgical Indication, run by University Hospital, Grenoble at 1 site in France.
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 4 inclusion and 9 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 9 May 2018. 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 France. 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 was stopped early. 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?
Magnetoencephalography (MEG) and Magnetic Resonance Imaging (MRI) data in tumor grade prediction (time frame: 1 week before exeresis). The study lists 2 primary outcomes in all. 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 9 May 2018.