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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

PARA-PET

Linked study record

Health condition

Health condition(s) or problem(s) studied:

primary hyperparathyroidism

Condition category

Condition code

Metabolic and Endocrine

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]

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]

Change in intended management approach, from bilateral neck exploration to minimally invasive parathyroidectomy, after first-line imaging strategy

Timepoint [1]

Multidisciplinary meeting - prior to surgery

Secondary outcome [1]

The proportion of a true-positive imaging-guided minimally invasive parathyroidectomy (MIP) resulting in biochemical cure

Timepoint [1]

At four or more weeks post surgery

Secondary outcome [2]

Cost-effectiveness of only FCH PET/CT diagnostic strategy vs conventional imaging

Timepoint [2]

Assessed at the conclusion of the study

Secondary outcome [3]

Diagnostic accuracy of each imaging test (FCH PET/CT, 4D CT, sestamibi SPECT/CT)

Timepoint [3]

At 1 month post surgery

Secondary outcome [4]

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]

At conclusion of study

Secondary outcome [5]

Environmental impact of each diagnostic strategy

Timepoint [5]

At conclusion of study

Secondary outcome [6]

Patient/consumer experience of each diagnostic strategy (FCH PET/CT vs conventional imaging with 4D CT, sestamibi SPECT/CT).

Timepoint [6]

One month post surgery

Secondary outcome [7]

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]

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?

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]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

4029 - Royal Brisbane Hospital

Recruitment postcode(s) [2]

4029 - Herston

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Queensland Technology Future Fund

Address [1]

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

RACP

Address [2]

Country [2]

Australia

Primary sponsor type

Government body

Name

Queensland Health Metro North Hospital and Health Service

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

University

Name [1]

University of Queensland

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro North Health Human Research Ethics Committee A

Ethics committee address [1]

https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/01/2025

Approval date [1]

28/04/2025

Ethics approval number [1]

Summary

Brief summary

Primary hyperparathyroidism is a common endocrine disease leading to considerable morbidity if untreated. Surgical resection of the overactive gland is the only curative treatment, with pre-operative localisation of the responsible gland(s) necessary to perform a minimally invasive surgical approach. The current standard of care in Australia is to undertake multimodal scans with neck ultrasound, [99mTc]Sestamibi SPECT/CT and four- dimensional computed tomography (4D CT).

 [18F]Fluorocholine (FCH) PET/CT is a novel imaging technique that is increasingly recognised as more accurate, with additional potential benefits including lower radiation exposure and shorter imaging time. 

This trial will compare the management impact of FCH PET/CT to conventional imaging. We hypothesise that FCH PET/CT will be as accurate as conventional imaging techniques while demonstrating lower radiation exposure, cost-effectiveness to the Australian health system and increased patient satisfaction.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof David Pattison

Address

Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD, 4006

Country

Australia

Phone

+61 7 3646 5442

Fax

[email protected]

Contact person for public queries

Name

Elizabeth Wootton

Address

Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD, 4006

Country

Australia

Phone

+61 7 3646 7955

Fax

[email protected]

Contact person for scientific queries

Name

Elizabeth Wootton

Address

Royal Brisbane and Women's Hospital, Butterfield St, Herston, QLD, 4006

Country

Australia

Phone

+61 7 3646 7955

Fax

[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?

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.

Trial Review

Documents added manually

Documents added automatically