Role of 18F-FDG PET/CT in the Evaluation of Cavernous Sinus Syndrome: a Pilot Study

NCT06721130 | Completed DMC

• 1 other identifier: 1134
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Cavernous sinus syndrome (CSS) can be caused by a wide range of inflammatory, malignant, benign, vascular and miscellaneous disorders. Even after modern advances, reaching the final etiological diagnosis remains a challenge in CSS. This study is planned to determine the role and incremental value of 18F-FDG PET/CT in characterising different cavernous sinus pathologies based on their metabolic activity and detecting extracranial involvement.

Conditions

Cavernous Sinus Syndrome; Cavernous Sinus Meningioma; Cavernous Sinus Lesions

Keywords

Cavernous Sinus Syndromes; Ophthalmoplegia; Positron Emission Tomography Computed Tomography; Fluorodeoxyglucose F18; Cavernous Sinus

Outcome Measures

Primary Outcomes (2)

• SUVmax of the cavernous sinus lesions on FDG PET/CT

  Standardized uptake value (SUV) will be calculated by drawing region of interest (ROI) in the cavernous sinus region both on the whole body and the dedicated brain image, while carefully excluding normal brain activity. If lesions in the bilateral cavernous sinuses will be present, SUVmax of both the lesions will be noted.

  From enrollment to the establishment of final diagnosis upto a period of three months

• Number of patients with extracranial sites of involvement on FDG PET/CT

  From enrollment to the establishment of final diagnosis upto 3 months

Study Arms (1)

Treatment naive patients presenting with Cavernous Sinus Syndrome with cavernous sinus lesion on MRI

Diagnostic Test: FDG radiotracer

Interventions

FDG radiotracer DIAGNOSTIC_TEST

Pilot study evaluating the role of FDG PET/CT in Cavernous sinus syndrome

Also known as: FDG PET/CT

Treatment naive patients presenting with Cavernous Sinus Syndrome with cavernous sinus lesion on MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive treatment naive patients of either sex with signs and symptoms of cavernous sinus syndrome attending the outpatient clinic in the Department of Neurology, Postgraduate Institute of medical Education \& Research, Chandigarh. Case definition for CSS- involvement of two or more cranial nerves (which pass through CS) or oculosympathetic fibers on the same side, or involvement of only cranial nerve in combination with a radiologically confirmed cavernous sinus lesion.

You may qualify if:

• Patients with age greater than or equal to 18 years,
• with newly diagnosed CSS,
• lesion seen on MRI in the CS, and
• willing to give written informed consent.

You may not qualify if:

• Pregnant and lactating patients
• Patients already being treated (including steroids)

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Cavernous Sinus Syndromes; Ophthalmoplegia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ocular Motility Disorders; Cranial Nerve Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 6, 2024
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: December 6, 2024

Record last verified: 2022-07

Locations

IN (1)