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Trial registered on ANZCTR


Registration number
ACTRN12621000618853
Ethics application status
Approved
Date submitted
11/03/2021
Date registered
24/05/2021
Date last updated
24/05/2021
Date data sharing statement initially provided
24/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical application of Intra-operative Confocal Laser Endomicroscopy for the Diagnosis of Giant Cell Arteritis: A Prospective Study
Scientific title
Clinical application of Intra-operative Confocal Laser Endomicroscopy for the Diagnosis of Giant Cell Arteritis: A Prospective Study
Secondary ID [1] 303666 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Giant cell arteritis 321058 0
Condition category
Condition code
Surgery 318865 318865 0 0
Other surgery
Inflammatory and Immune System 319257 319257 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 319966 0
Diagnosis / Prognosis
Comparator / control treatment
Control - tissue specimens are processed in the standardised fashion with haematoxylin and eosin stain (H&E) staining and viewed under a microscope by a pathologist.

Intervention - digital histological images of the artery are obtained intra-operatively using the confocal laser endomicroscope. These images are also reviewed by a pathologist.

The pathologist will compare the accuracy of diagnosis in the intervention arm (using CLE) to the gold standard in the control arm (traditional histology analysis).
Control group
Active

Outcomes
Primary outcome [1] 326818 0
To characterise the clinical utility of intra-operative CLE in the diagnosis of Giant Cell Arteritis

This will be assessed by a pathologist. For patients who have confirmed giant cell arteritis on normal histopathology (gold standard), their CLE images will also be reviewed to ascertain whether a diagnosis can be made of them, or if there are histological features (e.g. multinucleated giant cells, abnormal cytotexture) that are able to be distinguished. Through this comparison, an assessment of the clinical utility of intra-operative CLE in the diagnosis of Giant Cell Arteritis will be made.
Timepoint [1] 326818 0
Conclusion of study (~12 months)
Primary outcome [2] 327134 0
To characterise the sensitivity and specificity of intra-operative CLE in the diagnosis of Giant Cell Arteritis.

This will be assessed by a pathologist. For patients who have confirmed giant cell arteritis on normal histopathology (gold standard), their CLE images will also be reviewed to ascertain whether a diagnosis can be made of them. Through this comparison, an assessment of the sensitivity and specificity of intra-operative CLE in the diagnosis of Giant Cell Arteritis will be made.
Timepoint [2] 327134 0
Conclusion of study (~12 months)
Secondary outcome [1] 392768 0
No secondary outcome
Timepoint [1] 392768 0
No secondary outcome

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Categorical data will be calculated and analysed using Chi-Squared or Fisher’s Exact Test to examine any correlation between two data sets. Continuous data will be reported as mean with standard deviation and analysed using Student’s T/Analysis of Variance Tests of parametric variables, or with Mann-Whitney U/Kruskal-Wallis Test for non-parametric variables. A p-value of < 0.005 will be considered statistically significant. Our target sample size is based on feasible recruitment figures within a 12-month period and is not intended for any statistical power calculations. We believe that 30 participants within 12-months for a descriptive pilot study is reasonable and achievable.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
Date of last participant enrolment
Anticipated
21/03/2022
Actual
Date of last data collection
Anticipated
25/03/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18889 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 33394 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 308085 0
University
Name [1] 308085 0
Department of Surgery, Monash University
Country [1] 308085 0
Australia
Primary sponsor type
Hospital
Name
Monash Medical Centre
Address
Monash Medical Centre
246 Clayton Road, Clayton, VIC, 3168
Country
Australia
Secondary sponsor category [1] 308835 0
None
Name [1] 308835 0
Address [1] 308835 0
Country [1] 308835 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308071 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 308071 0
246 Clayton Road, Clayton, VIC, 3168
Ethics committee country [1] 308071 0
Australia
Date submitted for ethics approval [1] 308071 0
19/01/2021
Approval date [1] 308071 0
08/03/2021
Ethics approval number [1] 308071 0
RES-21-0000-036A

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109426 0
A/Prof Leon Lai
Address 109426 0
Monash Medical Centre
246 Clayton Road, Clayton, VIC, 3168
Country 109426 0
Australia
Phone 109426 0
+61 3 9594 5661
Fax 109426 0
Email 109426 0
[email protected]
Contact person for public queries
Name 109427 0
Tarundeep Dhaliwal
Address 109427 0
Monash Medical Centre
246 Clayton Road, Clayton, VIC, 3168
Country 109427 0
Australia
Phone 109427 0
+61 3 9594 6666
Fax 109427 0
Email 109427 0
[email protected]
Contact person for scientific queries
Name 109428 0
Leon Lai
Address 109428 0
Monash Medical Centre
246 Clayton Road, Clayton, VIC, 3168
Country 109428 0
Australia
Phone 109428 0
+61 3 9594 5661
Fax 109428 0
Email 109428 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be de-identified and published in peer-reviewed journal. Statistics may be presented as an aggregate of participant data.
There is no role for sharing individual participant data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

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