Cavernous Sinus SyndromeNCT06721130
Role of 18F-FDG PET/CT in the Evaluation of Cavernous Sinus Syndrome: a Pilot Study
An observational study of Cavernous Sinus Syndrome and Cavernous Sinus Meningioma, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cavernous Sinus Syndrome, Cavernous Sinus Meningioma, Cavernous Sinus Lesions
- What is being tested?
- FDG radiotracer
- How many people
- 54 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Pregnant and lactating patients
- Patients already being treated (including steroids)
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
About this 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.
- Being tested
- FDG radiotracer
- Keywords
- Cavernous Sinus Syndromes, Ophthalmoplegia, Positron Emission Tomography Computed Tomography, Fluorodeoxyglucose F18, Cavernous Sinus
- Medical subject headings
- Cavernous Sinus Syndromes, Ophthalmoplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG radiotracerDiagnostic test
Also called FDG PET/CT
Pilot study evaluating the role of FDG PET/CT in Cavernous sinus syndrome
| Study group | Role | What they receive |
|---|---|---|
| Treatment naive patients presenting with Cavernous Sinus Syndrome with cavernous sinus lesion on MRI | Not described Receives: Diagnostic Test: FDG radiotracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From enrollment to the establishment of final diagnosis upto 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cavernous Sinus SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajender Kumar, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721130
- Sponsor's protocol ID
- 1134
- Status last verified
- Jul 2022
- First submitted
- 27 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of 18F-FDG PET/CT in the Evaluation of Cavernous Sinus Syndrome: a Pilot Study
- ClinicalTrials.gov ID
- NCT06721130
- Acronym / sponsor ID
- 1134
- Keywords
- Cavernous Sinus Syndromes, Ophthalmoplegia, Positron Emission Tomography Computed Tomography, Fluorodeoxyglucose F18, Cavernous Sinus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment naive patients presenting with Cavernous Sinus Syndrome with cavernous sinus lesion on MRI | – | Diagnostic Test: FDG radiotracer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant and lactating patients
- Patients already being treated (including steroids)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG radiotracerAlso: FDG PET/CTPilot study evaluating the role of FDG PET/CT in Cavernous sinus syndrome | Diagnostic test | Treatment naive patients presenting with Cavernous Sinus Syndrome with cavernous sinus lesion on MRI |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cavernous Sinus Syndrome and Cavernous Sinus Meningioma, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.