Value of Radionuclide Cisternography

Fistula Clinical Trial

— VERTICAL  

Official title:

VALUE OF RADIONUCLIDE CISTERNOGRAPHY IN PATIENTS WITH CEREBROSPINAL FLUID LEAK

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02876614
• Other study ID #: 69HCL16_0543
• Status: Completed
• Phase: N/A
• First received: August 9, 2016
• Last updated: August 18, 2016
• Start date: January 2005
• Est. completion date: December 2005

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak
• CSF Leak
• Fistula

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	one week	No