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Trial registered on ANZCTR


Registration number
ACTRN12613001201763
Ethics application status
Approved
Date submitted
30/10/2013
Date registered
1/11/2013
Date last updated
1/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of heart function with positron emission tomography (PET) imaging: comparison to conventional cardiac gated blood pool scanning
Scientific title
In adult cancer patients having cardiac gated blood pool (CGBP) imaging what is the agreement with Ga-68 CGBP PET/CT imaging?
Secondary ID [1] 283493 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart (cardiac) function 290411 0
Condition category
Condition code
Cardiovascular 290801 290801 0 0
Other cardiovascular diseases
Cancer 290802 290802 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
If you agree to participate, in addition to the conventional scan that your doctor has already requested, you will undergo an additional scan on the PET scanner. A small amount of radioactive red blood cells will be injected into your vein. You will not require any additional needle pricks, as we will use the same small plastic tube (intravenous cannula) which was inserted into a vein as part of the conventional scan. Images of your heart will be performed for about 5-10 minutes.
Intervention code [1] 288199 0
Diagnosis / Prognosis
Comparator / control treatment
Conventional Cardiac Gated Blood Pool with Tc-99m labelled red blood cells. The conventional test is a nuclear medicine imaging test which involves labelling blood with a radioactive substance, and then measuring the amount of blood in the heart during different parts of the heart beat. A special camera, called a gamma camera, measures activity in the heart which is matched (also called “gated”) to your heart rhythm. This test is called a “cardiac gated blood pool scan” (CGBS). The amount of blood being pumped out of your heart, called the left ventricular ejection fraction (LVEF), can then be measured.
Control group
Active

Outcomes
Primary outcome [1] 290797 0
Level of agreement for estimation of left ventricular ejection fracture (LVEF) between CGPS PET/CT and conventional CGPS
Timepoint [1] 290797 0
Single time-point
Secondary outcome [1] 305304 0
Calculate the radiation dosimetry of CGPS PET/CT. This will be determined by obtaining additional images from head to pelvis in the first five patients and calculating the radiation exposure in each organ from the images obtained.
Timepoint [1] 305304 0
Single time-point

Eligibility
Key inclusion criteria
- Patient referred for cardiac gated blood pool scan at Peter MacCallum Cancer Centre
- Age >= 18
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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
Not yet recruiting
Date of first participant enrolment
Anticipated
25/11/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1638 0
Peter MacCallum Cancer Institute - East Melbourne

Funding & Sponsors
Funding source category [1] 288193 0
Self funded/Unfunded
Name [1] 288193 0
Physician Sponsored
Country [1] 288193 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Institute
Address
St Andrews Place
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 286919 0
None
Name [1] 286919 0
Address [1] 286919 0
Country [1] 286919 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290102 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 290102 0
Ethics Committee Secretariat
Peter MacCallum Cancer Centre
Level 4, 10 St Andrews Place
East Melbourne, VIC 3002
Ethics committee country [1] 290102 0
Australia
Date submitted for ethics approval [1] 290102 0
Approval date [1] 290102 0
28/10/2013
Ethics approval number [1] 290102 0
13/151

Summary
Brief summary
The study is comparing two techniques to assess heart 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 heart function.

Why might this test be needed? A "cardiac gated blood pool scan" (CGBS) is a commonly requested to scan to identify problems with your heart function. Impaired heart function can be a serious adverse effect of chemotherapy and other new anti-tumour agents. Depending on the type of treatment you are receiving, it is therefore important to identify any damage to the heart following treatment or to check heart function before starting treatment. If damage is found, the dose of your treatment may be reduced or a different type of treatment may be chosen.

How is the standard test performed? The conventional test is a nuclear medicine imaging test which involves labelling blood with a radioactive substance, and then measuring the amount of blood in the heart during different parts of the heart beat. A special camera, called a gamma camera, measures activity in the heart which is matched (also called “gated”) to your heart rhythm. This test is called a “cardiac gated blood pool scan” (CGBS). The amount of blood being pumped out of your heart, called the left ventricular ejection fraction (LVEF), can then be measured.

How is the new test for this study performed? The new test is performed by labelling your blood with a different radioactive substance, called gallium-68. This enables images to be obtained on a newer type of camera, called a positron emission tomography (PET) scanner.

What are the potential advantages of this new test? The PET scanner produces three-dimensional (3D) images of higher quality and in a shorter amount of time than the conventional test.

How might this study contribute to patient care? The knowledge acquired from this study will be used to validate this new test. If we can demonstrate that it is at least as good or better than current technology, it may replace the existing test in the future.

Trial details. This study aims to recruit 40 patients. Both the conventional and new CGBS will be performed in each patient, and the results compared. The new test involves an additional scan performed in a positron emission tomography (PET) scanner. Images of you heart will be performed for 5-10 minutes after being positioned on the bed of the PET scanner. The new scan will be performed shortly after the conventional scan.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43994 0
A/Prof Michael Hofman
Address 43994 0
Peter MacCallum Cancer Centre,
St Andrews Place,
East Melbourne VIC 3002
Country 43994 0
Australia
Phone 43994 0
+61 3 9656 1852
Fax 43994 0
Email 43994 0
[email protected]
Contact person for public queries
Name 43995 0
Michael Hofman
Address 43995 0
Peter MacCallum Cancer Centre,
St Andrews Place,
East Melbourne VIC 3002
Country 43995 0
Australia
Phone 43995 0
+61 3 9656 1852
Fax 43995 0
Email 43995 0
[email protected]
Contact person for scientific queries
Name 43996 0
Michael Hofman
Address 43996 0
Peter MacCallum Cancer Centre,
St Andrews Place,
East Melbourne VIC 3002
Country 43996 0
Australia
Phone 43996 0
+61 3 9656 1852
Fax 43996 0
Email 43996 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
No additional documents have been identified.