NCT02876614

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
10.7 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
Last Updated

August 24, 2016

Status Verified

August 1, 2016

Enrollment Period

11 months

First QC Date

August 9, 2016

Last Update Submit

August 18, 2016

Conditions

Keywords

radionuclide cisternographyCSF leakimaging

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who received a convocation for realization of RC

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebrospinal Fluid OtorrheaFistula

Condition Hierarchy (Ancestors)

Cerebrospinal Fluid LeakNeurologic ManifestationsNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesPathological Conditions, Anatomical

Study Officials

  • Elise LEVIGOUREUX, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 24, 2016

Study Start

January 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

August 24, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share