NCT07001059

Brief Summary

The purpose of this study is to evaluate whether the measure of the optic nerve sheath is a reliable diagnostic marker for giant cell arteritis

Trial Health

77
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

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 Progress26%
Sep 2025Mar 2028

First Submitted

Initial submission to the registry

May 22, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 4, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

May 22, 2025

Last Update Submit

September 8, 2025

Conditions

Giant Cell Arteritis (GCA)

Keywords

Giant Cell ArteritisOptic nerve sheathUltrasound

Outcome Measures

Primary Outcomes (1)

  • Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA)

    Area under the ROC curve (AUC) of the optic nerve sheath measurements obtained by ultrasound during the enrollment phase, using the final clinical expert diagnosis at 6 months as the reference standard. The clinical expert's evaluation will be blinded to the optic nerve sheath measurements.

    At the patient enrollment visit and at 6 months

Secondary Outcomes (8)

  • Assess the reproducibility of the optic nerve sheath diameter (ONSD) measurements by ultrasound.

    At the patient enrollment visit and at 6 months

  • Evaluate the diagnostic performance of ONSD in GCA.

    At the patient enrollment visit and at 6 months

  • Study the evolution of ONSD under treatment between M0 and M6 in patients with GCA.

    At the patient enrollment visit and at 6 months

  • Exploratory evaluation of ONSD according to the presence or absence of extracranial GCA.

    At the patient enrollment visit and at 6 months

  • Exploratory evaluation of ONSD based on the presence or absence of GCA with visual involvement.

    At the patient enrollment visit and at 6 months

  • +3 more secondary outcomes

Study Arms (1)

Orbital ultrasounds

EXPERIMENTAL

Orbital ultrasounds on patients suspected of GCA at the enrollment (M0) and at 6 months if the suspicion of GCA is confirmed after all the tests realized at the enrollment.

Diagnostic Test: orbital ultrasound

Interventions

orbital ultrasoundDIAGNOSTIC_TEST

orbital ultrasound at the beginning of the participation, and at 6 months after the inclusion.

Orbital ultrasounds

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with suspected GCA
  • Patient over 50 years

You may not qualify if:

  • Patient with history of GCA
  • Patient with a history of polymyalgia rheumatic (PMR) without initial PET scan
  • Patient with a history of retinal disease, demyelinating disease, or intracranial hypertension
  • Use of corticosteroids \> 0.5mg/kg in the last 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Rhumatology departement - Centre Hospitalier Aix en Provence

Aix-en-Provence, France

NOT YET RECRUITING

Rhumatology department - Centre Hospitalier Universitaire de Brest

Brest, France

NOT YET RECRUITING

Internal Medecine Department- CHU Caen

Caen, France

RECRUITING

Internal Medicine and Clinical Immulogy department - Centre Hospitalier Universitaire de Dijon

Dijon, France

NOT YET RECRUITING

Internal Medicine and VascularMedecine Department - Centre Hospitalier Universitaire de Nantes

Nantes, France

NOT YET RECRUITING

Internal Medicine department - Hôpital Saint-Antoine

Paris, France

NOT YET RECRUITING

Rhumatology department - Hôpital Bichat

Paris, France

NOT YET RECRUITING

Rhumatology department - Hôpital NOVO - Pontoise site

Pontoise, France

NOT YET RECRUITING

Rhumatology department - Centre Hospitalier Universitaire de Tours

Tours, France

NOT YET RECRUITING

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Omar AL TABAA, Dr

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryline DELATTRE

CONTACT

+330130754131maryline.delattre@ght-novo.fr

Mathilde WLODARCZYK

CONTACT

+330130754040mathilde.wlodarczyk@ght-novo.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

June 3, 2025

Study Start

September 4, 2025

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Last Updated

September 12, 2025

Record last verified: 2025-09

Locations

FR(9)