Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000509460
Ethics application status
Approved
Date submitted
7/05/2025
Date registered
23/05/2025
Date last updated
23/05/2025
Date data sharing statement initially provided
23/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised diagnostic imaging trial of [18F]FCH PET/CT vs conventional imaging for primary hyperparathyroidism
Scientific title
PARA-PET: a randomised diagnostic imaging trial of [18F]FCH PET/CT vs conventional imaging (4D-CT and sestamibi SPECT/CT) for primary hyperparathyroidism
Secondary ID [1] 313796 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PARA-PET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
primary hyperparathyroidism 336431 0
Condition category
Condition code
Metabolic and Endocrine 332951 332951 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will enrol eligible patients referred to the Endocrine Surgery department at one acute tertiary hospital site, the Royal Brisbane and Women’s Hospital (RBWH) in Brisbane, Australia.

After the informed consent process, participants will undergo [18F]fluorocholine (FCH) PET/CT at the RBWH Department of Nuclear Medicine & PET Services. This scan takes approximately 1 hour.. Images will be interpreted by two experienced nuclear medicine specialists in a blinded fashion.

Conventional imaging with sestamibi SPECT/CT and 4D CT will be performed unless already completed within the previous six months, and interpreted as per standard care by an experienced nuclear medicine specialist and radiologist respectively. All patients will receive a standard of care neck ultrasound to assist with operative planning. The duration of these imaging procedures will be determined by the local institutional protocol, in general a neck ultrasound takes approximately 1 hour, a 4D CT 1 hour and sestamibi SPECT/CT 4 hours.

All imaging techniques will be reviewed at a monthly multidisciplinary meeting, attended by representatives from Endocrinology, Endocrine Surgery, Nuclear Medicine and Radiology. Participants will be randomised 1:1 to the order in which the imaging modality (FCH PET/CT or conventional imaging with sestamibi SPECT/CT and 4DCT) will be reviewed first. The study investigator will record the intended management plan at baseline and following first- and second-line imaging. The intended surgical approach, either minimally invasive parathyroidectomy or bilateral neck exploration, will be documented according to a schema of positive, equivocal and negative results of each imaging technique.

As current best practice, it is expected that the majority of participants will proceed to neck surgery within 12 weeks of randomisation, performed by an experienced Endocrine Surgeon. Clinical outcomes of participants will be followed up at one month and six months following definitive surgery. Additional analyses will include accuracy of each imaging modality, inter-observer agreement after a second blind read of all imaging at three months, health economic assessment, comparison of radiation exposure, assessment of environmental impact and measurement of patient satisfaction with imaging techniques.
Intervention code [1] 330384 0
Diagnosis / Prognosis
Comparator / control treatment
Sestamibi SPECT/CT comprising sestamibi planar and SPECT/CT images acquired after injection of 99mTc-sestamibi and 4D CT will be performed according to local institutional protocol.
Control group
Active

Outcomes
Primary outcome [1] 340500 0
Change in intended management approach, from bilateral neck exploration to minimally invasive parathyroidectomy, after first-line imaging strategy
Timepoint [1] 340500 0
Multidisciplinary meeting - prior to surgery
Secondary outcome [1] 444271 0
The proportion of a true-positive imaging-guided minimally invasive parathyroidectomy (MIP) resulting in biochemical cure
Timepoint [1] 444271 0
At four or more weeks post surgery
Secondary outcome [2] 444274 0
Cost-effectiveness of only FCH PET/CT diagnostic strategy vs conventional imaging
Timepoint [2] 444274 0
Assessed at the conclusion of the study
Secondary outcome [3] 444275 0
Diagnostic accuracy of each imaging test (FCH PET/CT, 4D CT, sestamibi SPECT/CT)
Timepoint [3] 444275 0
At 1 month post surgery
Secondary outcome [4] 444276 0
Difference in total radiation exposure between using first line conventional imaging compared to first line FCH PET/CT, in order to identify a true-positive imaging-guided MIP with resultant biochemical cure at one month
Timepoint [4] 444276 0
At conclusion of study
Secondary outcome [5] 444277 0
Environmental impact of each diagnostic strategy
Timepoint [5] 444277 0
At conclusion of study
Secondary outcome [6] 444278 0
Patient/consumer experience of each diagnostic strategy (FCH PET/CT vs conventional imaging with 4D CT, sestamibi SPECT/CT).
Timepoint [6] 444278 0
One month post surgery
Secondary outcome [7] 444279 0
Inter-observer agreement of FCH PET/CT, 4D CT and sestamibi SPECT/CT interpretation, between two independent observers, for the first and second (three months later) blinded interpretations
Timepoint [7] 444279 0
Initial interpretation at time of imaging compared to three months after surgery

Eligibility
Key inclusion criteria
1. Aged 18 or more years of age
2. Biochemically confirmed PTH-dependent hypercalcaemia, defined as:
• Serum calcium elevated above the reference range (eg adjusted for serum albumin >2.6mmol/L or ionized calcium concentration >1.32mmol/L) with PTH in or above the reference range
3. Criteria met for parathyroidectomy, confirmed by an endocrinologist
• Symptoms of hyperparathyroidism;
• Asymptomatic aged under 50 years;
• Osteopenia, osteoporosis or significant bone loss over time (defined as a reduction greater than the least significant change defined by the International Society for Clinical Densitometry);
• Raised urine calcium excretion (>10mmol/day), renal calculus or deteriorating renal function (eGFR2.75mmol/L
4. Able and willing to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Estimated glomerular filtration rate below 30ml/min, performed within 3 months of screening
2. Current pregnancy or breastfeeding
3. Clinical suspicion of parathyroid carcinoma, as determined by referring clinician or study investigator
4. Use of colchicine, if unable to with-hold for 48 hours prior to FCH PET/CT, judged by referring clinician
5. MEN1 syndrome, defined as either:
a. Genetic: documented MEN1 gene mutation
b. Familial: presence of one main MEN1 manifestation alongside first degree relative with MEN1 syndrome
c. Clinical: presence of two main MEN1 manifestations
6. Previous parathyroid surgery
7. Proven or suspected familial hypocalciuric hypocalcaemia (FHH)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomised according to a computer-generated randomisation sequence concealed from study personnel.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using Queensland Health REDCap by a study investigator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis will be performed with assistance from QIMR Berghofer according to both per-protocol and intention-to-treat principles.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2027
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27522 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 43634 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 43635 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 318263 0
Charities/Societies/Foundations
Name [1] 318263 0
Queensland Technology Future Fund
Country [1] 318263 0
Australia
Funding source category [2] 318271 0
Charities/Societies/Foundations
Name [2] 318271 0
RACP
Country [2] 318271 0
Australia
Primary sponsor type
Government body
Name
Queensland Health Metro North Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 320647 0
None
Name [1] 320647 0
Address [1] 320647 0
Country [1] 320647 0
Other collaborator category [1] 283378 0
University
Name [1] 283378 0
University of Queensland
Address [1] 283378 0
Country [1] 283378 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316903 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 316903 0
Ethics committee country [1] 316903 0
Australia
Date submitted for ethics approval [1] 316903 0
22/01/2025
Approval date [1] 316903 0
28/04/2025
Ethics approval number [1] 316903 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139378 0
A/Prof David Pattison
Address 139378 0
Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD, 4006
Country 139378 0
Australia
Phone 139378 0
+61 7 3646 5442
Fax 139378 0
Email 139378 0
[email protected]
Contact person for public queries
Name 139379 0
Elizabeth Wootton
Address 139379 0
Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD, 4006
Country 139379 0
Australia
Phone 139379 0
+61 7 3646 7955
Fax 139379 0
Email 139379 0
[email protected]
Contact person for scientific queries
Name 139380 0
Elizabeth Wootton
Address 139380 0
Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD, 4006
Country 139380 0
Australia
Phone 139380 0
+61 7 3646 7955
Fax 139380 0
Email 139380 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At end of trial

To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Metro North Health - [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.