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Trial registered on ANZCTR


Registration number
ACTRN12613000820707
Ethics application status
Approved
Date submitted
18/07/2013
Date registered
25/07/2013
Date last updated
17/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of radiation dose reduction and image quality of single acquisition, two contrast-injection computed tomography chest/abdomen/pelvis scans compared to the standard two phase imaging protocol for disease staging of oncology patients.
Scientific title
Assessment of radiation dose reduction and image quality of single acquisition, two contrast-injection computed tomography chest/abdomen/pelvis scans compared to the standard two phase imaging protocol for disease staging of oncology patients.
Secondary ID [1] 282860 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CT radiation dose 289672 0
Condition category
Condition code
Other 289990 289990 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Contrast enhanced CT of the chest/abdomen/pelvis is acquired by using single bolus (80ml at 3 ml/sec) contrast injection with the chest segment imaged in arterial phase while the abdomen/pelvis segment is imaged in the portal venous phase. The area in the lower chest and in the upper abdomen is imaged in both segments resulting in extra unnecessary radiation dose to the patient.
This method is the standard practice of performing a CT of the chest, abdomen and pelvis.

The aim of this study is to change the imaging protocol for CT chest/abdomen/pelvis so that the radiation dose is reduced and to assess the image quality compared to the current imaging protocol.

Our study protocol involves one continuous scan of the chest, abdomen and pelvis with a pause after imaging the chest as described below.
It is achieved by administering the contrast in two doses, 65 ml for the first injection and 15ml for the second injection, in total 80 ml. The first injection is for the chest and the second for the abdomen and pelvis. There is a 13 second pause between the two injections and both are injected at 2.5 ml/sec.
The lower chest and upper abdomen is therefore not imaged twice, as in the standard practice, reducing the radiation dose to the patient.
Our study protocol takes approximately 3 minutes to acquire the images, which is about twice as long as the standard practice.
Intervention code [1] 287555 0
Diagnosis / Prognosis
Comparator / control treatment
Patients who require new staging CT chest/abdomen/pelvis and who have had previous CT chest/abdomen/pelvis imaging using the standard protocol will be selected for this study.
The previous CT needs to have been performed within 1 year of the study CT protocol for the patient to be included in the study.
The image quality of the study protocol CT will be compared to their previous imaging and determine if imaging quality is not affected.
Control group
Historical

Outcomes
Primary outcome [1] 290037 0
Measure of the radiation dose reduction of a single pass chest/abdomen/pelvis CT protocol in oncology patients compared to a standard two stage arterial and venous phase imaging protocol.
Effective doses are calculated by multiplying a dose-length product (DLP) and a constant called Edlp.
DLP is provided by CT software and recorded for every CT scan performed.
Edlp depends on the region of body scanned but constant for that region and the type of CT scanner used.
Timepoint [1] 290037 0
At the time of performing the scan.
Primary outcome [2] 290038 0
Evaluation of the diagnostic image quality of a single pass chest/abdomen/pelvis CT protocol assessed by the Regions of Interest (ROI’s) measure of the degrees of enhancement (attentuation) in the descending aorta and mid liver
Timepoint [2] 290038 0
At the time of performing the scan.
Secondary outcome [1] 303822 0
Time per scan
Timepoint [1] 303822 0
At the time of performing the scan.
Secondary outcome [2] 303823 0
Ease of performing the scans (qualitative assessment by radiographers)
Timepoint [2] 303823 0
At the time of performing the scan.

Eligibility
Key inclusion criteria
1) Referred oncology patients undergoing staging contrast enhanced CT chest/abdomen/pelvis who have had previous CT chest/abdomen/pelvis imaging performed within 1 year.
2) Only adult patients (age >/= 18) will be imaged using the proposed protocol.
3) Only outpatients will be included in the study.
4) Signed informed consent form.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Oncology patients referred for non-enhanced CT chest/abdomen/pelvis for any reason and including contrast allergy and renal failure.
2. Severe heart failure (this can impair adequate tissue contrast enhancement).
3. Extensive progression of cancer in the period between the two scans. This could prevent direct comparison image quality of the two scans.
4. Pregnancy.
5. Inability to sign own consent (intellectual or mental impairment).

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1345 0
The Alfred - Prahran
Recruitment postcode(s) [1] 7178 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 287636 0
Hospital
Name [1] 287636 0
The Alfred
Address [1] 287636 0
Street address:

55 Commercial Rd, Melbourne VIC 3004.

Postal address:

The Alfred
PO Box 315
Prahran VIC 3181
Country [1] 287636 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
Street address:

55 Commercial Rd, Melbourne VIC 3004.

Postal address:

The Alfred
PO Box 315
Prahran VIC 3181
Country
Australia
Secondary sponsor category [1] 286378 0
None
Name [1] 286378 0
Address [1] 286378 0
Country [1] 286378 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289607 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 289607 0
Street address:

55 Commercial Rd, Melbourne VIC 3004.

Postal address:

The Alfred
PO Box 315
Prahran VIC 3181
Ethics committee country [1] 289607 0
Australia
Date submitted for ethics approval [1] 289607 0
17/07/2013
Approval date [1] 289607 0
26/07/2013
Ethics approval number [1] 289607 0
14/13

Summary
Brief summary
The aim of this research is to determine the way to obtain the best possible images of the chest, abdomen, and pelvis with Computed Tomography (CT) that delivers the lowest amount of radiation to patients. We will be comparing the standard way we take images to a new protocol (protocol means the way the images are taken).

The standard CT protocol of the chest, abdomen and pelvis is done in two steps, the chest and abdomen is scanned followed by the lower part of the abdomen and the pelvis. This results in a part of the abdomen being scanned twice. The new protocol that we would like to test takes all the images in one step, from the chest to the pelvis with no overlap. This is why the amount of radiation used can be reduced.
The image quality of your CT using the new protocol will be compared to the image quality of the CT which was done with the standard protocol. If the image quality of this research protocol is deemed optimal, it may be adopted as the standard way of performing CT of the chest, abdomen and pelvis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41550 0
Dr Ernest Lekgabe
Address 41550 0
Street address:

55 Commercial Rd, Melbourne VIC 3004.

Postal address:

The Alfred
PO Box 315
Prahran VIC 3181
Country 41550 0
Australia
Phone 41550 0
+61 3 90760357
Fax 41550 0
Email 41550 0
e.lekgabe@alfred.org.au
Contact person for public queries
Name 41551 0
Dr Ernest Lekgabe
Address 41551 0
Street address:

55 Commercial Rd, Melbourne VIC 3004.

Postal address:

The Alfred
PO Box 315
Prahran VIC 3181
Country 41551 0
Australia
Phone 41551 0
+61 3 90760357
Fax 41551 0
Email 41551 0
e.lekgabe@alfred.org.au
Contact person for scientific queries
Name 41552 0
Dr Ernest Lekgabe
Address 41552 0
Street address:

55 Commercial Rd, Melbourne VIC 3004.

Postal address:

The Alfred
PO Box 315
Prahran VIC 3181
Country 41552 0
Australia
Phone 41552 0
+61 3 90760357
Fax 41552 0
Email 41552 0
e.lekgabe@alfred.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary