ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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)

Renal Oncocytoma (Benign)

Condition category

Condition code

Cancer

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]

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]

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]

Each Sestamibi SPEC/CT will be interpreted within 1 week of the imaging study.

Secondary outcome [1]

Nil

Timepoint [1]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Western Australian Urological Research Organisation

Address [1]

47 Oxford Close West Leederville WA 6007

Country [1]

Australia

Primary sponsor type

Individual

Name

Thomas England

Address

Western Urology
26 McCourt St
West Leederville
WA 6007

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Ronnie Low

Address [1]

Envision Medical Imaging 178-190 Cambridge St Wembley WA 6014

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Ronald Cohen

Address [2]

Uropath 47 Oxford Cl West Leederville WA 6007

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St John of God Research Ethics Comittee

Ethics committee address [1]

12 Salvado Road 
Subiaco 
WA 6008

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/07/2019

Approval date [1]

19/09/2019

Ethics approval number [1]

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

Mr Thomas England

Address

Western Urology 26 McCourt St West Leederville WA 6007

Country

Australia

Phone

+61 425883022

Fax

[email protected]

Contact person for public queries

Name

Thomas England

Address

Western Urology 26 McCourt St West Leederville WA 6007

Country

Australia

Phone

+61 425883022

Fax

[email protected]

Contact person for scientific queries

Name

Thomas England

Address

Western Urology 26 McCourt St West Leederville WA 6007

Country

Australia

Phone

+61 425883022

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No 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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2023	Informed consent form				Participant Booklet - Participant Information, Par... [More Details]	Study-related document.pdf
2042	Other				Study Overview	Study-related document.pdf

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