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Trial registered on ANZCTR


Registration number
ACTRN12624000151538
Ethics application status
Approved
Date submitted
19/12/2023
Date registered
16/02/2024
Date last updated
16/02/2024
Date data sharing statement initially provided
16/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Detection of parathyroid glands with autofluoresence during thyroid and parathyroid surgery
Scientific title
Assessing Efficacy of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands during Endocrine Surgery in adults
Secondary ID [1] 309770 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thyroid nodules 330174 0
Thyroid cancer 330175 0
Multinodular goitres 330176 0
Graves' disease 330177 0
Primary hyperparathyroidism 330178 0
Renal hyperparathyroidism 330179 0
Condition category
Condition code
Surgery 327054 327054 0 0
Surgical techniques
Metabolic and Endocrine 329257 329257 0 0
Thyroid disease
Metabolic and Endocrine 329258 329258 0 0
Other endocrine disorders
Cancer 329485 329485 0 0
Thyroid

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME:
Assessing Benefits of Near Infrared Autofluorescence Detection for Identifying Parathyroid Glands during Endocrine Surgery

MATERIALS USED:
The intervention will evaluate whether the PTeye (Medtronic, Santa Barbara, CA) a probe-based near infrared autofluorescence detection device that consists of a console, a handheld fibre optic probe, a foot pedal and an external power supply, can assist surgeons to identify PGs during thyroid and parathyroid operations confidently.

PROCEDURE:
A standard thyroid or parathyroid operation will take place and use of he PTeye will occur if the patient has been randomised to the intervention arm
The handheld fibre optic probe is initially applied to the thyroid gland to record a “baseline” for the device. This will take approximately 10 seconds. The probe will subsequently be used on tissue that is thought to be parathyroid tissue.
The use of the PTeye would be expected to add another 5 minutes to the operative time.

WHO WILL DELIVER:
Endocrine surgeons as Alfred Health

TRAINING
Surgeons have been provided training by the inventor of the device from Vanderbilt University, Nashville, TN. The Principal Investigator has also spent time at Vanderbilt University with a surgeon who has had the greatest experience in the use of the PTeye.

MODE OF DELIVERY:
The intervention will occur with an individual surgeon and patient at the time they are undergoing the relevant endocrine operation.

NUMBER OF TIMES:
Approximately 6 times per week, dependent on the individual surgeon’s schedule

LOCATION OF INTERVENTION:
Alfred Hospital operating theatres
Intervention code [1] 327666 0
Treatment: Surgery
Comparator / control treatment
A standard thyroid or parathyroid operation will be undertaken without any form of imaging being used at the time of surgery.

Types of thyroid surgery include removal of half or the whole thyroid gland. At the time of surgery, the parathyroid glands are identified and preserved. This is currently done by visual identification of the gland(s) by the surgeon.

For parathyroid surgery, any abnormal parathyroid gland will be removed.
Control group
Active

Outcomes
Primary outcome [1] 336916 0
The primary endpoint of this study is to evaluate the confidence level of surgeons in identifying parathyroid glands during thyroid and parathyroid surgery before and after using the PTeye
Timepoint [1] 336916 0
This information is recorded at the time of surgery
Secondary outcome [1] 430151 0
Post-operative hypoparathyroidism rates
Timepoint [1] 430151 0
PTH levels will be checked at Day 0,Day 1, 2 weeks and 3 months post surgery
Secondary outcome [2] 430968 0
Reduction in the number of frozen sections being used
Timepoint [2] 430968 0
This will be recorded intraoperatively
Secondary outcome [3] 430969 0
Confidence of surgical trainees in identifying parathyroid glands
Timepoint [3] 430969 0
This will be assessed intraoperatively

Eligibility
Key inclusion criteria
All adults (greater and equal to 18 years old) patients with thyroid disease who will be undergoing hemi or total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland).

All adults (greater and equal to 18 years old) patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy.

All adults (greater and equal to 18 years old) patients with thyroid cancer and will be undergoing re-operative or completion thyroidectomy.

All adults (greater and equal to 18 years old) patients with primary, secondary or tertiary hyperparathyroidism who will be undergoing parathyroid surgery.

All adults (greater and equal to 18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children and minors
Pregnant women
Patients with very high anaesthetic risks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/01/2024
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
100
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25953 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 41787 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 313957 0
Hospital
Name [1] 313957 0
The Alfred Hospital
Country [1] 313957 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Rd, Prahran 3181 Victoria
Country
Australia
Secondary sponsor category [1] 317540 0
None
Name [1] 317540 0
Address [1] 317540 0
Country [1] 317540 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313094 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 313094 0
55 Commercial Road, Prahran 3181, Victoria
Ethics committee country [1] 313094 0
Australia
Date submitted for ethics approval [1] 313094 0
22/06/2023
Approval date [1] 313094 0
01/08/2023
Ethics approval number [1] 313094 0
HREC/98077/Alfred-2023

Summary
Brief summary
This study aims to assess whether use of a new near infrared imaging device (PTeye device) during thyroid and some parathyroid operations enables surgeons to confidently identify parathyroid glands.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with thyroid disease, including primary hyperparathyroidism and thyroid cancer who will be undergoing thyroid or parathyroid surgery for exploration and/or tissue removal purposes.

Study details
Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Both groups will undergo their scheduled thyroid/parathyroid surgery per standard procedures, however one of the groups will also have their tissue imaged using the PTeye device. It is anticipated that use of the PTeye device will add 5 minutes to the overall procedure time.

It is hoped this research will determine whether use of the PTeye device enables surgeons to more confidently identify parathyroid tissue during surgery. By assisting the surgeon in correctly identifying parathyroid glands, this device may improve the quality of the operation performed on the patient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126982 0
Dr Meei Yeung
Address 126982 0
Alfred Health, 55 Commercial Rd, Prahran, Victoria 3144
Country 126982 0
Australia
Phone 126982 0
+61412925015
Fax 126982 0
Email 126982 0
m.yeung@alfred.org.au
Contact person for public queries
Name 126983 0
Dr Meei Yeung
Address 126983 0
Alfred Health, 55 Commercial Rd, Prahran 3181, Victoria
Country 126983 0
Australia
Phone 126983 0
+61390763290
Fax 126983 0
Email 126983 0
pteye.trial@gmail.com
Contact person for scientific queries
Name 126984 0
Dr Meei Yeung
Address 126984 0
Alfred Health, 55 Commercial Rd, Prahran, Victoria 3144
Country 126984 0
Australia
Phone 126984 0
+61390763290
Fax 126984 0
Email 126984 0
m.yeung@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
9/1/24 - 30/6/24
Available to whom?
Only researchers and collaborators (Vanderbilt University) will be able to access the de-identified data
Available for what types of analyses?
Analysis includes data to achieve the aims in the approved proposal
How or where can data be obtained?
Data will be hosted in the Alfred Health Sharepoint and access will only be allocated via password by the Principal Investigator
PI can be contacted at: pteye.trial@gmail.com


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.

Documents added automatically
No additional documents have been identified.