Trial Review

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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] 282907 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney function 289127 0
Condition category
Condition code
Renal and Urogenital 289467 289467 0 0
Kidney disease
Cancer 289468 289468 0 0
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] 287143 0
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] 289569 0
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] 289569 0
Single time-point
Secondary outcome [1] 302749 0
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] 302749 0
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?
No
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
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 982 0
Peter MacCallum Cancer Institute - East Melbourne

Funding & Sponsors
Funding source category [1] 287273 0
Self funded/Unfunded
Name [1] 287273 0
Physician Sponsored
Country [1] 287273 0
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] 286026 0
Hospital
Name [1] 286026 0
Peter MacCallum Cancer Centre
Address [1] 286026 0
St Andrews Place
East Melbourne VIC 3002
Country [1] 286026 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289253 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 289253 0
Ethics Committee Secretariat
Peter MacCallum Cancer Centre
Level 4, 10 St Andrews Place
East Melbourne, VIC 3002
Ethics committee country [1] 289253 0
Australia
Date submitted for ethics approval [1] 289253 0
Approval date [1] 289253 0
04/04/2012
Ethics approval number [1] 289253 0
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 39990 0
Dr Michael Hofman
Address 39990 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 39990 0
Australia
Phone 39990 0
613 9656 1852
Fax 39990 0
Email 39990 0
[email protected]
Contact person for public queries
Name 39991 0
Dr Michael Hofman
Address 39991 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 39991 0
Australia
Phone 39991 0
613 9656 1852
Fax 39991 0
Email 39991 0
[email protected]
Contact person for scientific queries
Name 39992 0
Dr Michael Hofman
Address 39992 0
Peter MacCallum Cancer Centre
St Andrews Place
East Melbourne VIC 3002
Country 39992 0
Australia
Phone 39992 0
613 9656 1852
Fax 39992 0
Email 39992 0
[email protected]

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
SourceTitleYear of PublicationDOI
Embase68Ga-EDTA PET/CT imaging and plasma clearance for glomerular filtration rate quantification: Comparison to conventional 51Cr-EDTA.2015https://dx.doi.org/10.2967/jnumed.114.147843
N.B. These documents automatically identified may not have been verified by the study sponsor.