Cavernous Sinus SyndromeNCT07917858
Whole-Body ⁶⁸Ga-FAPI PET/CT in Cavernous Sinus Syndrome: A Prospective Comparison With ¹⁸F-FDG PET/CT
An observational study of Cavernous Sinus Syndrome, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
The goal of this observational study is to evaluate the diagnostic utility of whole-body ⁶⁸Ga-FAPI PET/CT in adults with cavernous sinus syndrome (CSS) in whom magnetic resonance imaging (MRI) failed to establish the underlying cause. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cavernous Sinus Syndrome
- What is being tested?
- FAPI tracer and FDG-PET
- Type of treatment
- Injection or infusion
- How many people
- 21 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2025to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population consisted of consecutive adult patients presenting with clinically diagnosed cavernous sinus syndrome (CSS) at a tertiary care academic referral center between January 2023 and May 2024. Eligible participants had contrast-enhanced MRI demonstrating cavernous sinus pathology but without a definitive etiological diagnosis. All participants underwent paired whole-body ¹⁸F-FDG PET/CT and ⁶⁸Ga-FAPI-46 PET/CT prior to initiation of definitive therapy as part of the diagnostic evaluation.
Who may be able to join
- Adults aged 18 years or older.
- Clinical diagnosis of cavernous sinus syndrome (CSS), defined as involvement of two or more cranial nerves (III, IV, V1, V2, or VI) on the same side, or involvement of a single cranial nerve in the presence of a radiologically confirmed cavernous sinus lesion.
- Contrast-enhanced MRI demonstrating cavernous sinus pathology but failing to establish a definitive etiological diagnosis.
- Ability and willingness to provide written informed consent.
- Not receiving definitive etiology-directed therapy before completion of both PET/CT examinations.
Who cannot join
- Pregnant or lactating women.
- Unwilling or unable to provide written informed consent.
- Uncontrolled hyperglycemia precluding performance of ¹⁸F-FDG PET/CT.
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute of Medical Education and Research, Chandigarh, Chandigarh 160012
Chandigarh, Chandigarh, 160012
About this study
The goal of this observational study is to evaluate the diagnostic utility of whole-body ⁶⁸Ga-FAPI PET/CT in adults with cavernous sinus syndrome (CSS) in whom magnetic resonance imaging (MRI) failed to establish the underlying cause. The study also compares the performance of ⁶⁸Ga-FAPI PET/CT with paired ¹⁸F-FDG PET/CT.
The main questions it aims to answer are:
Can whole-body ⁶⁸Ga-FAPI PET/CT detect and characterize cavernous sinus lesions and disease extent in patients with MRI-indeterminate CSS? Does ⁶⁸Ga-FAPI PET/CT provide superior lesion conspicuity and help identify safer biopsy sites compared with ¹⁸F-FDG PET/CT? Researchers will compare whole-body ⁶⁸Ga-FAPI PET/CT with paired ¹⁸F-FDG PET/CT to evaluate lesion detection, quantitative imaging parameters, disease extent, and their impact on identifying appropriate biopsy targets.
Read the detailed description
Cavernous sinus syndrome (CSS) is a clinically heterogeneous condition resulting from involvement of the cavernous sinus and its neurovascular contents. Although contrast-enhanced magnetic resonance imaging (MRI) is the imaging modality of choice for evaluating cavernous sinus pathology, it frequently cannot establish the underlying etiology because infectious, inflammatory, and neoplastic disorders often demonstrate overlapping imaging appearances. Establishing a tissue diagnosis is further complicated by the technical difficulty and potential risks associated with direct cavernous sinus biopsy. Consequently, identification of contiguous disease extension or extracranial lesions that can be safely sampled is an important component of the diagnostic work-up.
This prospective observational study evaluates the diagnostic utility of whole-body 68Ga-FAPI-46 PET/CT in adult patients with cavernous sinus syndrome in whom MRI failed to establish an etiological diagnosis. All enrolled participants undergo paired whole-body 18F-FDG PET/CT and 68Ga-FAPI-46 PET/CT prior to initiation of definitive therapy. The interval between the two PET/CT examinations does not exceed six days. MRI is performed as part of the standard diagnostic evaluation before PET/CT imaging.
The study compares the two PET tracers with respect to:
Detection of cavernous sinus lesions. Delineation of locoregional disease extension, including meningeal, pituitary/sellar, skull base, orbital, sinonasal, and adjacent soft-tissue involvement.
Detection of extracranial disease. Quantitative imaging parameters, including lesion SUVmax, background brain SUVmean, and target-to-background ratio (TBR).
Ability to identify safer and more accessible biopsy targets that may facilitate histopathological diagnosis.
PET/CT images are independently interpreted by experienced nuclear medicine physicians who are aware of the clinical presentation and MRI findings but blinded to the final diagnosis. Lesion uptake, disease distribution, and extracranial findings are assessed qualitatively, while SUVmax, background brain SUVmean, and TBR are measured for quantitative comparison. Final diagnosis is established using histopathological examination whenever feasible or established clinicoradiological diagnostic criteria when tissue confirmation is unavailable. Biopsy sites are selected following multidisciplinary discussion based on accessibility, anticipated diagnostic yield, and procedural safety. Participants are subsequently followed after initiation of etiology-directed therapy to document clinical and imaging response.
Statistical analyses include paired comparison of quantitative PET parameters using the Wilcoxon signed-rank test, comparison of lesion detection rates using the McNemar test, and comparison of quantitative imaging parameters between fungal infection and IgG4-related disease using the Mann-Whitney U test. Statistical significance is defined as a two-sided P value <0.05.
- Conditions
- Cavernous Sinus Syndrome
- Being tested
- FAPI tracer, FDG-PET
- Keywords
- Fibroblast Activation Protein, Positron Emission Tomography Computed Tomography, Immunoglobulin G4-Related Disease, Cavernous sinus syndromes, Fluorodeoxyglucose F18
- Medical subject headings
- Cavernous Sinus Syndromes, Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI tracerDiagnostic test
Pilot study evaluating the role of FAPI PET/CT in Cavernous sinus syndrome
FDG-PETDrug
Whole-body ¹⁸F-fluorodeoxyglucose (¹⁸F-FDG) PET/CT performed after at least 6 hours of fasting and confirmation of blood glucose <200 mg/dL. ¹⁸F-FDG was administered intravenously at a dose of 3.7 MBq/kg body weight. Imaging was acquired approximately 60 minutes after tracer injection from the vertex to mid-thigh with an additional dedicated brain acquisition. This served as the comparator imaging modality for paired evaluation with ⁶⁸Ga-FAPI-46 PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| adult patients with cavernous sinus syndrome in whom MRI failed to establish etiological diagnosis | Not described Receives: Diagnostic Test: FAPI tracer; Drug: FDG-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of ⁶⁸Ga-FAPI PET/CT for detection of cavernous sinus lesions compared with paired ¹⁸F-FDG PET/CT
Comparison of cavernous sinus lesion detection rates between whole-body ⁶⁸Ga-FAPI PET/CT and paired ¹⁸F-FDG PET/CT on a lesion basis using the McNemar test. A lesion is considered positive when tracer uptake exceeds adjacent background
Measured: Baseline (prior to initiation of definitive therapy; both PET/CT examinations performed within 6 days of each other).
Secondary outcomes (4)
Comparison of lesion target-to-background ratio (TBR) between ⁶⁸Ga-FAPI PET/CT and ¹⁸F-FDG PET/CT
Comparison of lesion TBR calculated as lesion SUVmax divided by background brain SUVmean for paired lesions.
Measured: Baselines
Comparison of lesion SUVmax between ⁶⁸Ga-FAPI PET/CT and ¹⁸F-FDG PET/CT
Comparison of maximum standardized uptake value (SUVmax) of paired cavernous sinus lesions between the two PET tracers.
Measured: Baseline
Proportion of participants in whom ⁶⁸Ga-FAPI PET/CT identified an alternative biopsy site
Percentage of participants in whom whole-body ⁶⁸Ga-FAPI PET/CT identified a safer and more accessible contiguous or extracranial lesion suitable for tissue diagnosis instead of direct cavernous sinus biopsy.
Measured: Baseline
Detection of clinically relevant extracranial disease by whole-body ⁶⁸Ga-FAPI PET/CT
Number of participants with disease-related extracranial lesions identified on whole-body ⁶⁸Ga-FAPI PET/CT
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Jun 2025
- Primary completion30 Jun 2026
- Study completion30 Nov 2026 (estimated)
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
- 21 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
- NCT07917858
- Sponsor's protocol ID
- ChandigarhPGIMER1
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Body ⁶⁸Ga-FAPI PET/CT in Cavernous Sinus Syndrome: A Prospective Comparison With ¹⁸F-FDG PET/CT
- ClinicalTrials.gov ID
- NCT07917858
- Acronym / sponsor ID
- ChandigarhPGIMER1
- Conditions
- Cavernous Sinus Syndrome
- Keywords
- Fibroblast Activation Protein, Positron Emission Tomography Computed Tomography, Immunoglobulin G4-Related Disease, Cavernous sinus syndromes, Fluorodeoxyglucose F18
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 Nov 2026 (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.
The goal of this observational study is to evaluate the diagnostic utility of whole-body ⁶⁸Ga-FAPI PET/CT in adults with cavernous sinus syndrome (CSS) in whom magnetic resonance imaging (MRI) failed to establish the underlying cause. The study also compares the performance of ⁶⁸Ga-FAPI PET/CT with paired ¹⁸F-FDG PET/CT.
The main questions it aims to answer are:
Can whole-body ⁶⁸Ga-FAPI PET/CT detect and characterize cavernous sinus lesions and disease extent in patients with MRI-indeterminate CSS? Does ⁶⁸Ga-FAPI PET/CT provide superior lesion conspicuity and help identify safer biopsy sites compared with ¹⁸F-FDG PET/CT? Researchers will compare whole-body ⁶⁸Ga-FAPI PET/CT with paired ¹⁸F-FDG PET/CT to evaluate lesion detection, quantitative imaging parameters, disease extent, and their impact on identifying appropriate biopsy targets.
Detailed description
Cavernous sinus syndrome (CSS) is a clinically heterogeneous condition resulting from involvement of the cavernous sinus and its neurovascular contents. Although contrast-enhanced magnetic resonance imaging (MRI) is the imaging modality of choice for evaluating cavernous sinus pathology, it frequently cannot establish the underlying etiology because infectious, inflammatory, and neoplastic disorders often demonstrate overlapping imaging appearances. Establishing a tissue diagnosis is further complicated by the technical difficulty and potential risks associated with direct cavernous sinus biopsy. Consequently, identification of contiguous disease extension or extracranial lesions that can be safely sampled is an important component of the diagnostic work-up.
This prospective observational study evaluates the diagnostic utility of whole-body 68Ga-FAPI-46 PET/CT in adult patients with cavernous sinus syndrome in whom MRI failed to establish an etiological diagnosis. All enrolled participants undergo paired whole-body 18F-FDG PET/CT and 68Ga-FAPI-46 PET/CT prior to initiation of definitive therapy. The interval between the two PET/CT examinations does not exceed six days. MRI is performed as part of the standard diagnostic evaluation before PET/CT imaging.
The study compares the two PET tracers with respect to:
Detection of cavernous sinus lesions. Delineation of locoregional disease extension, including meningeal, pituitary/sellar, skull base, orbital, sinonasal, and adjacent soft-tissue involvement.
Detection of extracranial disease. Quantitative imaging parameters, including lesion SUVmax, background brain SUVmean, and target-to-background ratio (TBR).
Ability to identify safer and more accessible biopsy targets that may facilitate histopathological diagnosis.
PET/CT images are independently interpreted by experienced nuclear medicine physicians who are aware of the clinical presentation and MRI findings but blinded to the final diagnosis. Lesion uptake, disease distribution, and extracranial findings are assessed qualitatively, while SUVmax, background brain SUVmean, and TBR are measured for quantitative comparison. Final diagnosis is established using histopathological examination whenever feasible or established clinicoradiological diagnostic criteria when tissue confirmation is unavailable. Biopsy sites are selected following multidisciplinary discussion based on accessibility, anticipated diagnostic yield, and procedural safety. Participants are subsequently followed after initiation of etiology-directed therapy to document clinical and imaging response.
Statistical analyses include paired comparison of quantitative PET parameters using the Wilcoxon signed-rank test, comparison of lesion detection rates using the McNemar test, and comparison of quantitative imaging parameters between fungal infection and IgG4-related disease using the Mann-Whitney U test. Statistical significance is defined as a two-sided P value <0.05.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients with cavernous sinus syndrome in whom MRI failed to establish etiological diagnosis | – | Diagnostic Test: FAPI tracer, Drug: FDG-PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of consecutive adult patients presenting with clinically diagnosed cavernous sinus syndrome (CSS) at a tertiary care academic referral center between January 2023 and May 2024. Eligible participants had contrast-enhanced MRI demonstrating cavernous sinus pathology but without a definitive etiological diagnosis. All participants underwent paired whole-body ¹⁸F-FDG PET/CT and ⁶⁸Ga-FAPI-46 PET/CT prior to initiation of definitive therapy as part of the diagnostic evaluation.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Clinical diagnosis of cavernous sinus syndrome (CSS), defined as involvement of two or more cranial nerves (III, IV, V1, V2, or VI) on the same side, or involvement of a single cranial nerve in the presence of a radiologically confirmed cavernous sinus lesion.
- Contrast-enhanced MRI demonstrating cavernous sinus pathology but failing to establish a definitive etiological diagnosis.
- Ability and willingness to provide written informed consent.
- Not receiving definitive etiology-directed therapy before completion of both PET/CT examinations.
Key exclusion criteria (3 listed)
- Pregnant or lactating women.
- Unwilling or unable to provide written informed consent.
- Uncontrolled hyperglycemia precluding performance of ¹⁸F-FDG PET/CT.
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 |
|---|---|---|
| FAPI tracerPilot study evaluating the role of FAPI PET/CT in Cavernous sinus syndrome | Diagnostic test | adult patients with cavernous sinus syndrome in whom MRI failed to establish etiological diagnosis |
| FDG-PETWhole-body ¹⁸F-fluorodeoxyglucose (¹⁸F-FDG) PET/CT performed after at least 6 hours of fasting and confirmation of blood glucose <200 mg/dL. ¹⁸F-FDG was administered intravenously at a dose of 3.7 MBq/kg body weight. Imaging was acquired approximately 60 minutes after tracer injection from the vertex to mid-thigh with an additional dedicated brain acquisition. This served as the comparator imaging modality for paired evaluation with ⁶⁸Ga-FAPI-46 PET/CT. | Drug | adult patients with cavernous sinus syndrome in whom MRI failed to establish etiological diagnosis |
Primary outcome
Diagnostic performance of ⁶⁸Ga-FAPI PET/CT for detection of cavernous sinus lesions compared with paired ¹⁸F-FDG PET/CT
Time frame: Baseline (prior to initiation of definitive therapy; both PET/CT examinations performed within 6 days of each other).
Comparison of cavernous sinus lesion detection rates between whole-body ⁶⁸Ga-FAPI PET/CT and paired ¹⁸F-FDG PET/CT on a lesion basis using the McNemar test. A lesion is considered positive when tracer uptake exceeds adjacent background
4 secondary outcomes
Comparison of lesion target-to-background ratio (TBR) between ⁶⁸Ga-FAPI PET/CT and ¹⁸F-FDG PET/CT
Time frame: Baselines
Comparison of lesion SUVmax between ⁶⁸Ga-FAPI PET/CT and ¹⁸F-FDG PET/CT
Time frame: Baseline
Proportion of participants in whom ⁶⁸Ga-FAPI PET/CT identified an alternative biopsy site
Time frame: Baseline
Detection of clinically relevant extracranial disease by whole-body ⁶⁸Ga-FAPI PET/CT
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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, 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic performance of ⁶⁸Ga-FAPI PET/CT for detection of cavernous sinus lesions compared with paired ¹⁸F-FDG PET/CT (time frame: Baseline (prior to initiation of definitive therapy; both PET/CT examinations performed within 6 days of each other).). 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 5 Nov 2026.