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

December 3, 2024 updated by: Rajender Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Post Graduate Institute of Medical education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnant and lactating patients
  2. Patients already being treated (including steroids)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment naive patients presenting with Cavernous Sinus Syndrome with cavernous sinus lesion on MRI
Diagnostic test: FDG radiotracer
Pilot study evaluating the role of FDG PET/CT in Cavernous sinus syndrome
Other Names:
  • FDG PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUVmax of the cavernous sinus lesions on FDG PET/CT
Time Frame: From enrollment to the establishment of final diagnosis upto a period of three months
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
Time Frame: From enrollment to the establishment of final diagnosis upto 3 months
From enrollment to the establishment of final diagnosis upto 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 6, 2024

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1134

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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