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OpenTrials
Completed

NCT Number: NCT06721130

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

FDG radiotracer

Diagnostic Test

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

Other names: FDG PET/CT

Primary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Dec 6, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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