Value of Radionuclide Cisternography | NCT02876614

Studies
Value of Radionuclide Cisternography

NCT02876614

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Aug 24, 2016Estimated

Enrollment

113Actual

Phase

Not provided

Conditions

CSF Leak
Fistula

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Dec 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Aug 9, 2016

First Submission Date that Met QC Criteria

Aug 18, 2016

First Posted Date

Aug 24, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2016

Last Update Posted Date

Aug 24, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

113Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients who received a convocation for realization of RC

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elise LEVIGOUREUX, MD	Hospices Civils de Lyon	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002558	Cerebrospinal Fluid Otorrhea
D005402	Fistula

Ancestor Terms

ID	Term
D065634	Cerebrospinal Fluid Leak
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided