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Value of Radionuclide Cisternography (VERTICAL)

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ClinicalTrials.gov Identifier: NCT02876614
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : August 24, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

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.


Condition or disease
CSF Leak Fistula

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Study Type : Observational
Actual Enrollment : 113 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: VALUE OF RADIONUCLIDE CISTERNOGRAPHY IN PATIENTS WITH CEREBROSPINAL FLUID LEAK
Study Start Date : January 2005
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients who received a convocation for realization of RC
Criteria

Inclusion Criteria:

  • patients who received a convocation for realization of RC (extraction with GERA, software of Nuclear Medicine)

Exclusion Criteria:

  • patients who received a convocation for realization of RC with "valve" protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876614


Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Elise LEVIGOUREUX, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02876614     History of Changes
Other Study ID Numbers: 69HCL16_0543
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: August 24, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospices Civils de Lyon:
radionuclide cisternography
CSF leak
imaging

Additional relevant MeSH terms:
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Fistula
Cerebrospinal Fluid Leak
Pathological Conditions, Anatomical
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries