Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000153617
Ethics application status
Not required
Date submitted
14/08/2005
Date registered
15/08/2005
Date last updated
10/06/2021
Date data sharing statement initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of Dipyridamole in Improving the False Negative Rate in Pre-Operative Parathyroid Adenoma Localisation Using 99mTc Sestamibi
Scientific title
The role of Dipyridamole in Improving the False Negative Rate in Pre-Operative Parathyroid Adenoma Localisation Using 99mTc Sestamibi
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parathyroid Adenoma 246 0
Condition category
Condition code
Cancer 277 277 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The use of Dipyridamole in Improving the False Negative Rate in Pre-Operative Parathyroid Adenoma Localisation Using 99mTc Sestamibi.
Dipyridamole is used to enhance the uptake of Tc99m-Sestamibi in repeat parathyroid imaging.
Intervention code [1] 184 0
Diagnosis / Prognosis
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327 0
Improved detection of parathyroid Adenoma's.
Timepoint [1] 327 0
Secondary outcome [1] 730 0
Improved surgical outcome in the removal of Parathyroid Adenoma's.
Timepoint [1] 730 0

Eligibility
Key inclusion criteria
Previous negative 99mTc Sestamibi parathyroid scan. No subsequent parathyroid surgery. Abnormal parathyroid Hormone (PTH ) levels. Strong clinical suspicion of parathyroid adenoma. Permission of referring doctor. Informed consent of patient.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age younger than 18 years, pregnancy, unable to gain informed consent, unstable cardiac disease, Asthma, hypotension, hypersensitivity to aspirin or dipyridamole.

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)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
11/12/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 332 0
Self funded/Unfunded
Name [1] 332 0
Country [1] 332 0
Primary sponsor type
Individual
Name
Robert Williams
Address
Country
Secondary sponsor category [1] 264 0
Individual
Name [1] 264 0
Dr G Mack Jost
Address [1] 264 0
Country [1] 264 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 1275 0
North East Health Wangaratta
Ethics committee address [1] 1275 0
Ethics committee country [1] 1275 0
Australia
Date submitted for ethics approval [1] 1275 0
Approval date [1] 1275 0
Ethics approval number [1] 1275 0

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

Contacts
Principal investigator
Name 35281 0
Address 35281 0
Country 35281 0
Phone 35281 0
Fax 35281 0
Email 35281 0
Contact person for public queries
Name 9373 0
Robert Williams
Address 9373 0
9 Moran Court
Wangaratta VIC 3677
Country 9373 0
Australia
Phone 9373 0
+61 3 57222345
Fax 9373 0
Email 9373 0
[email protected]
Contact person for scientific queries
Name 301 0
Robert Williams
Address 301 0
9 Moran Court
Wangaratta VIC 3677
Country 301 0
Australia
Phone 301 0
+61 3 57222345
Fax 301 0
Email 301 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.