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Trial registered on ANZCTR


Registration number
ACTRN12619000715178
Ethics application status
Approved
Date submitted
6/05/2019
Date registered
13/05/2019
Date last updated
28/10/2019
Date data sharing statement initially provided
13/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Using Specialised Imaging to Differentiate Incidentally Found Renal Masses
Scientific title
Differentiating Renal Oncocytoma from Renal Cell Carcinoma Using Sestamibi Imaging
Secondary ID [1] 298091 0
Nil known
Universal Trial Number (UTN)
U1111-1232-5082
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma (Malignant) 312601 0
Renal Oncocytoma (Benign) 312602 0
Condition category
Condition code
Cancer 311111 311111 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
99m Tc-Sestamibi SPEC/CT is a nuclear imaging study used to investigate ischaemic heart disease and parathyroid nodules. Recently its use in renal mass imaging has increased as early research has shown its ability to help differentiate benign renal oncocytomas from malignant renal cell carcinomas.

Brand Name of 99m Tc-Sestamibi Tracer - Cardiolite
Dose administered to patient is 925 MBq
Effective radioactivity dose to patient is 5.32 mSv (with CT)
75-95 minutes must pass prior to imaging to enable effective renal uptake
Imaging takes approximately 30 min
Intervention code [1] 314386 0
Diagnosis / Prognosis
Comparator / control treatment
Comparator - as per the selection criteria all participants selected for recruitment must be having a renal biopsy in the near future as part of the ongoing investigation for their undiagnosed renal mass.

The histopathological diagnosis following the biopsy will be compared to the findings of the sestamibi scan.
Control group
Active

Outcomes
Primary outcome [1] 319970 0
The objective of this study is to establish whether the 99mTc-sestamibi tracer is effective in its ability to differentiate renal cell carcinoma from oncocytoma.

Findings from the Sestamibi scan (ie. likely presence of renal cell carcinoma, oncocytoma, or other) will be compared to the histopathological diagnosis following biopsy.

An accurate Sestamibi finding will be one that strongly suggests oncocytoma as per the radiological interpretation and is associated with a histopathological diagnosis of oncocytoma from the tissue sample.

Timepoint [1] 319970 0
Each Sestamibi SPEC/CT will be interpreted within 1 week of the imaging study.
Secondary outcome [1] 370078 0
Nil
Timepoint [1] 370078 0
Nil

Eligibility
Key inclusion criteria
1) Patient with a renal mass detected with an imaging study where the radiological features of the mass make it hard to distinguish between renal cell carcinoma and renal oncocytoma.
2) Patient is scheduled to have a renal biopsy to determine the histopathological diagnosis of the mass in the near future.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Under 18 years of age

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation not performed
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The IBM SPSS Statistics v20 program was used to calculate the statistical significance of 99m Tc-Sestamibi imaging to differentiate renal oncocytoma from renal cell carcinoma.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
24/10/2019
Date of last participant enrolment
Anticipated
1/01/2021
Actual
Date of last data collection
Anticipated
1/04/2021
Actual
Sample size
Target
204
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302619 0
Charities/Societies/Foundations
Name [1] 302619 0
Western Australian Urological Research Organisation
Country [1] 302619 0
Australia
Primary sponsor type
Individual
Name
Thomas England
Address
Western Urology
26 McCourt St
West Leederville
WA 6007
Country
Australia
Secondary sponsor category [1] 302622 0
None
Name [1] 302622 0
Address [1] 302622 0
Country [1] 302622 0
Other collaborator category [1] 280678 0
Individual
Name [1] 280678 0
Ronnie Low
Address [1] 280678 0
Envision Medical Imaging
178-190 Cambridge St
Wembley WA
6014
Country [1] 280678 0
Australia
Other collaborator category [2] 280685 0
Individual
Name [2] 280685 0
Ronald Cohen
Address [2] 280685 0
Uropath
47 Oxford Cl
West Leederville
WA 6007
Country [2] 280685 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303252 0
St John of God Research Ethics Comittee
Ethics committee address [1] 303252 0
12 Salvado Road
Subiaco
WA 6008
Ethics committee country [1] 303252 0
Australia
Date submitted for ethics approval [1] 303252 0
08/07/2019
Approval date [1] 303252 0
19/09/2019
Ethics approval number [1] 303252 0
1529

Summary
Brief summary
What is the purpose of this study?
The purpose is to investigate the possible role of specialised imaging called Sestamibi SEPC/CT in the diagnosis of renal masses.

Who is it for?
You are eligible to participate in this study if you are an adult that has had a renal mass detected and are scheduled to undergo a renal biopsy in the near future.

Study details
All willing and suitable participants will undergo specialised imaging involving a scan that takes approximately 45 minutes. The results of the imaging study will be compared with the results of the renal biopsy to be arranged as per normal by the patients urologist.

If proven to be effective in its ability to differentiate renal oncocytomas from renal cell carcinoma the sestamibi imaging technique could be more frequently used in the standard investigation of renal masses detected on abdominal imaging. In doing so the number of invasive renal biopsies may decline.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93018 0
Mr Thomas England
Address 93018 0
Western Urology
26 McCourt St
West Leederville
WA 6007
Country 93018 0
Australia
Phone 93018 0
+61 425883022
Fax 93018 0
Email 93018 0
[email protected]
Contact person for public queries
Name 93019 0
Thomas England
Address 93019 0
Western Urology
26 McCourt St
West Leederville
WA 6007
Country 93019 0
Australia
Phone 93019 0
+61 425883022
Fax 93019 0
Email 93019 0
[email protected]
Contact person for scientific queries
Name 93020 0
Thomas England
Address 93020 0
Western Urology
26 McCourt St
West Leederville
WA 6007
Country 93020 0
Australia
Phone 93020 0
+61 425883022
Fax 93020 0
Email 93020 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 participant information will remain private and confidential. Exceptions may apply when discussed with their urologist.


What supporting documents are/will be available?




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.