CSF LeakVERTICALNCT02876614
Value of Radionuclide Cisternography
An observational study of CSF Leak and Fistula, run by Hospices Civils de Lyon.
Trial summary
Radionuclide cisternography (RC) is a nuclear medicine examination based on intrathecal injection of [111In]diethylenetriaminepentaacetic acid ([111In]DTPA). It is prescribed for two recommendations: detection of cerebrospinal fluid (CSF) leak/fistula and diagnosis of normal pressure hydrocephalus. Read more about this study
- Who is it for?
- Any age
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Dec 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who received a convocation for realization of RC
Who may be able to join
- patients who received a convocation for realization of RC (extraction with GERA, software of Nuclear Medicine)
Who cannot join
- patients who received a convocation for realization of RC with "valve" protocol
About this study
Official title: VALUE OF RADIONUCLIDE CISTERNOGRAPHY IN PATIENTS WITH CEREBROSPINAL FLUID LEAK
Radionuclide cisternography (RC) is a nuclear medicine examination based on intrathecal injection of [111In]diethylenetriaminepentaacetic acid ([111In]DTPA). It is prescribed for two recommendations: detection of cerebrospinal fluid (CSF) leak/fistula and diagnosis of normal pressure hydrocephalus.
In the search part of CSF leak/fistula, RC offers the benefit of a 24-hour study of CSF unlike other reference tests.
Read more
In addition to SPECT/CT imaging, the radiopharmacist performs sampling in nasal cavities and throat of the patient to collect a possible flow of CSF.
These samples are analysed by radioactivity measurements and bring an added value to the exam.
The interest of this examination for management of CSF leak/fistula remains unclear.
The aim of this study is to identify and analyse results of all RC examinations performed since 2005 in the Nuclear Medicine department of the Neurological Hospital.
The full analysis of patients will allow discussing the role of RC in management of CSF leak/fistulae in clinical practice.
- Keywords
- radionuclide cisternography, CSF leak, imaging
- Medical subject headings
- Cerebrospinal Fluid Otorrhea, Fistula
What is being measured
The primary outcome is the main question the study is designed to answer.
RC /SPECT/CT imaging
Results of RC including results of SPECT/CT imaging and results of swabs counting (nasal cavities and throat or ear if applicable)
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startJan 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CSF LeakStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elise LEVIGOUREUX, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876614
- Sponsor's protocol ID
- 69HCL16_0543
- Acronym
- VERTICAL
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 24 Aug 2016
- 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 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VALUE OF RADIONUCLIDE CISTERNOGRAPHY IN PATIENTS WITH CEREBROSPINAL FLUID LEAK
- ClinicalTrials.gov ID
- NCT02876614
- Acronym / sponsor ID
- VERTICAL / 69HCL16_0543
- Keywords
- radionuclide cisternography, CSF leak, imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 24 Aug 2016 (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.
Radionuclide cisternography (RC) is a nuclear medicine examination based on intrathecal injection of [111In]diethylenetriaminepentaacetic acid ([111In]DTPA). It is prescribed for two recommendations: detection of cerebrospinal fluid (CSF) leak/fistula and diagnosis of normal pressure hydrocephalus.
In the search part of CSF leak/fistula, RC offers the benefit of a 24-hour study of CSF unlike other reference tests.
In addition to SPECT/CT imaging, the radiopharmacist performs sampling in nasal cavities and throat of the patient to collect a possible flow of CSF.
These samples are analysed by radioactivity measurements and bring an added value to the exam.
The interest of this examination for management of CSF leak/fistula remains unclear.
The aim of this study is to identify and analyse results of all RC examinations performed since 2005 in the Nuclear Medicine department of the Neurological Hospital.
The full analysis of patients will allow discussing the role of RC in management of CSF leak/fistulae in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who received a convocation for realization of RC
Key inclusion criteria (1 listed)
- patients who received a convocation for realization of RC (extraction with GERA, software of Nuclear Medicine)
Key exclusion criteria (1 listed)
- patients who received a convocation for realization of RC with "valve" protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RC /SPECT/CT imaging
Time frame: one week
Results of RC including results of SPECT/CT imaging and results of swabs counting (nasal cavities and throat or ear if applicable)
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 2016.
- 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.
Elise LEVIGOUREUX, MD principal investigator
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
An observational study of CSF Leak and Fistula, run by Hospices Civils de Lyon.
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 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 2016. Status can change between updates, so confirm with the study contact before making plans.
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 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?
RC /SPECT/CT imaging (time frame: one week). 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 24 Aug 2016.