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Value of Radionuclide Cisternography (VERTICAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02876614
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : August 24, 2016
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
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

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 identifier (NCT number): NCT02876614

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

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Responsible Party: Hospices Civils de Lyon 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

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