None listed
Conditions
Brief summary
Giant cell arteritis is an inflammatory condition affecting the blood vessels of the head and neck, and it requires prompt diagnosis and treatment. The current gold standard for diagnosis involves an operation to biopsy the superficial temporal artery and examine this tissue specimen under the microscope by a pathologist. A new technology called confocal laser endomicroscopy (CLE) has recently been developed to aid intra-operative diagnosis of various conditions. It involves applying a laser microscope to the tissue of interest during a surgical procedure to create a digital histological image. CLE has been investigated in gastroenterology, and other fields of Neurosurgery involving brain tumours with promising results. However, it is yet to be investigated in the diagnosis of giant cell arteritis. This study aims to evaluate the clinical utility, sensitivity and specificity of intra-operative CLE in the diagnosis of giant cell arteritis. Patients who are undergoing a superficial temporal artery biopsy are eligible for this study. If CLE is found to be accurate, then this may obviate the need to perform a biopsy of the superficial temporal artery during the operation. This will expose patients to less harm, and therefore has the potential to change surgical practice moving forward.
Interventions
Giant Cell Arteritis (GCA) is a form of vasculitis affecting medium to large sized vessels, most commonly in the head and neck. The gold standard for diagnosis is to perform a superficial temporal artery biopsy. A novel technology called confocal laser endomicroscopy (CLE) has recently been developed to provide real time intra-operative histological images, thereby enabling instant diagnosis. This technology as been applied extensively in the field of Gastroenterology, and more recently in Neuro
Giant Cell Arteritis (GCA) is a form of vasculitis affecting medium to large sized vessels, most commonly in the head and neck. The gold standard for diagnosis is to perform a superficial temporal artery biopsy. A novel technology called confocal laser endomicroscopy (CLE) has recently been developed to provide real time intra-operative histological images, thereby enabling instant diagnosis. This technology as been applied extensively in the field of Gastroenterology, and more recently in Neurosurgery in relation to intra-cranial tumour resections with promising results. However, its role in diagnosis beyond these conditions is yet to be evaluated. This study seeks to evaluate the utility of intra-operative confocal laser endomicroscopy in the diagnosis of GCA. All patients who are suspected of having GCA and are deemed to require a superficial temporal artery biopsy by a Consultant Neurosurgeon are eligible for this study. The operation will proceed as planned. However, there will be two additional small steps. Firstly, a fluorescent dye called sodium fluorescein will be administered intravenously during the operation. This dye aids diagnosis by helping to differentiate between normal and abnormal tissue. It has been used safely in previously studies and is very routinely used in other fields of medicine. Secondary, a handheld probe from the CLE device will be placed on the superficial temporal artery to obtain CLE images. These images will then be transferred across a secure network for review by a Pathologist. The operation will then proceed as normal with a specimen of the superficial temporal artery being taken for histology. The CLE images will then be compared to tissue biopsy results to determine its accuracy in diagnosis. There are no significant risks anticipated from the application of this device, and the added operating time is anticipated to be 15 minutes. The anticipated duration of this procedure without the aforementioned steps is approximately 20-30 minutes.
Sponsors
Monash Medical Centre
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age above 18 years Participants undergoing a superficial temporal artery biopsy for suspected Giant Cell Arteritis, as deemed to be required by a Consultant Neurosurgeon
Exclusion criteria
Age below 18, inability to provide informed consent, pregnancy, previous reaction to sodium fluorescein, allergy to shellfish or contrast media, and concurrent use of a beta-blockers or ACE inhibitor
Outcome results
None listed