ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000845730

Ethics application status

Approved

Date submitted

12/05/2013

Date registered

1/08/2013

Date last updated

20/03/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

Using Positron Emission Tomography (PET) imaging to measure kidney function

Scientific title

In adults having Cr-51 EDTA glomerular filtration rate (GFR) estimation, what is the agreement with Ga-68 EDTA PET/CT?

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Kidney function

Condition category

Condition code

Renal and Urogenital

Kidney disease

Cancer

Any cancer

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

1. Ga-68 EDTA PET/CT scan (15-20 minute duration)
2. Small blood sample taken at several time points (2, 3, 4hrs) to count radioactivity which is used to determine renal function

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Conventional Cr-51 EDTA GFR plasma clearance. The same blood samples taken to count Ga-68 radioactivity, is also used to count Cr-51, so both can be directly compared.

Control group

Active

Outcomes

Primary outcome [1]

Compare Ga-68 EDTA PET/CT calculated glomerular filtration rate (GFR) with results of Cr-51 EDTA. The GFR is calculated from the blood samples taken, and also from the PET scan.

Timepoint [1]

Single time-point

Secondary outcome [1]

Correlate assessment of differential or regional renal function with results of prior renal imaging. The contribution of each kidney to overall kidney function can be calculated from the PET scan. This will be compared to any prior tests that been performed for this purpose, usually a Tc-99m DMSA planar or SPECT/CT scan.

Timepoint [1]

Single time-point

Eligibility

Key inclusion criteria

- Patient referred for Cr-51 EDTA study at our institution
- Age >= 18 years
- Written informed consent has been provided. One of the investigators will personally meet each candidate to explain the study and obtain written informed consent.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Participant is not able to tolerate supine position on PET/CT bed for the duration of the PET/CT acquisitions, is not cooperative, or needs continuous nursing (e.g. patient from Intensive Care Unit).
- Pregnancy
- Breast-feeding

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

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2012

Actual

1/06/2012

Date of last participant enrolment

Anticipated

31/12/2013

Actual

25/10/2013

Date of last data collection

Anticipated

Actual

25/10/2013

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Peter MacCallum Cancer Institute - East Melbourne

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Physician Sponsored

Address [1]

Peter MacCallum Cancer Institute
St Andrews Place
East Melbourne VIC 3002

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Michael Hofman

Address

Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Peter MacCallum Cancer Centre

Address [1]

St Andrews Place
East Melbourne VIC 3002

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peter MacCallum Cancer Centre Ethics Committee

Ethics committee address [1]

Ethics Committee Secretariat
Peter MacCallum Cancer Centre
Level 4, 10 St Andrews Place
East Melbourne, VIC 3002

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

04/04/2012

Ethics approval number [1]

12/07

Summary

Brief summary

The study is comparing two different techniques to assess kidney function in patients referred to the Peter MacCallum Cancer Institute. 

Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been referred to the Peter MacCallum Cancer Institute for assessment of kidney function. 

Trial Details. The determination of kidney function is utilised for a wide range of clinical decision making. At Peter MacCallum Cancer Centre, common clinical indications include dose adjustment for renally excreted chemotherapy agents (eg. carboplatin), determination of overall and split renal function prior to abdominal radiotherapy and monitoring of renal function during radionuclide therapy. Radionuclide techniques such as 51Cr-ethylenediaminetetraacetic acid (EDTA) blood clearance counting is a well-established method for estimation of GFR but requires blood samples from the patient at multiple time points and requires a well counter to accurately measure radioactivity at each time point which is not available in many nuclear medicine facilities. Positron emission tomography (PET) offers several advantages for imaging the kidneys over the conventional nuclear medicine technique. It has an order of magnitude higher sensitivity for radiotracer detection, enables dynamic tomographic (three dimensional) imaging, incorporates scatter and attenuation correction enabling accurate quantification of regional uptake and has superior spatial and temporal resolution. EDTA can be labelled with 68Ga, a positron emitting isotope which can be imaged on a PET/CT scanner. 68Ga EDTA PET/CT offers a non-invasive imaging-based alternative to 51Cr EDTA for GFR estimation. 68Ga EDTA PET/CT also has the ability to assess both overall and differential or regional renal function in a single study. Currently, many patients undergo both a 51Cr EDTA and a 99mTc-DMSA or 99mTc-DTPA to calculate overall and regional function, respectively. Although 68Ga EDTA standalone PET has been performed, there is limited experience and no data on its use in the PET/CT era or utility in comparison to 51Cr EDTA for GFR estimation. There are also no published reports, to our knowledge, using 68Ga EDTA to assess regional renal function. All participants in this study will undergo two different techniques to evaluate kidney function. This involves having an injection into a vein of a small of dose of two radioactive substances (68Ga and 51Cr-EDTA). A 20 minute PET scan is then performed looking at your kidneys. A small amount of blood is taken at 2, 3 and 4 hours.

Trial website

Trial related presentations / publications

1. Hofman M, Binns D, Johnston V, Siva S, Thompson M, Eu P, Collins M, Hicks RJ. 
68Ga-EDTA PET/CT imaging and plasma clearance for glomerular filtration rate
quantification: comparison to conventional 51Cr-EDTA. J Nucl Med. 2015
Mar;56(3):405-9. doi: 10.2967/jnumed.114.147843. PubMed PMID: 25678493.
2. Hofman MS, Hicks RJ. Gallium-68 EDTA PET/CT for Renal Imaging. Semin Nucl Med.
2016 Sep;46(5):448-61. doi: 10.1053/j.semnuclmed.2016.04.002. Review. PubMed
PMID: 27553470.

Public notes

Contacts

Principal investigator

Name

Dr Michael Hofman

Address

Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002

Country

Australia

Phone

613 9656 1852

Fax

michael.hofman@petermac.org

Contact person for public queries

Name

Michael Hofman

Address

Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002

Country

Australia

Phone

613 9656 1852

Fax

michael.hofman@petermac.org

Contact person for scientific queries

Name

Michael Hofman

Address

Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002

Country

Australia

Phone

613 9656 1852

Fax

michael.hofman@petermac.org

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	68Ga-EDTA PET/CT imaging and plasma clearance for glomerular filtration rate quantification: Comparison to conventional 51Cr-EDTA.	2015	https://dx.doi.org/10.2967/jnumed.114.147843

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically