Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001170617
Ethics application status
Approved
Date submitted
23/10/2014
Date registered
6/11/2014
Date last updated
3/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Using Positron Emission Tomography Scan (PET scan) to improve diagnosis of pulmonary embolism.
Scientific title
In patients with malignancy, is V/Q PET/CT as accurate as CTPA for diagnosing acute pulmonary embolism?
Secondary ID [1] 285534 0
None
Universal Trial Number (UTN)
Trial acronym
PECAN study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary embolism 293351 0
Malignancy 293389 0
Condition category
Condition code
Blood 293625 293625 0 0
Clotting disorders
Cancer 293628 293628 0 0
Any cancer
Respiratory 293670 293670 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will undergo both

- Ga-68 Ventilation/Perfusion (V/Q) PET/CT: a small quantity of a substance called Galligas, which are particles labelled with a radioactive substance called Ga-68, is breathed in and thereby deposited into your lungs. After this, you will be required to lay still on the PET/CT camera bed for about 10 minutes whilst images are obtained. Whilst you are in the PET/CT scanner, you are then injected with a substance called Ga-MAA via the intravenous catheter. Ga-MAA stands for Ga-68 macroaggregated albumin (MAA) and is radioactive substance that localises in your lungs’ blood vessels. You will then be imaged again for a further 10 minutes.


- CT Pulmonary angiography (CTPA) : an intravenous catheter (small plastic tube) will be put into a vein in your arm. Intravenous contrast agent will be injected into a vein in your arm, and CT scan performed. You will be imaged with the CT camera for 1 minute.

Whenever it will be possible, both lung PET/CT and CTPA will be performed in the same evaluation on a PET/CT camera in the PET Centre. If it is not possible for practical considerations, lung PET/CT and CTPA will be performed separately within 24 hours.
Intervention code [1] 290477 0
Diagnosis / Prognosis
Comparator / control treatment
Conventional CT Pulmonary angiography (CTPA)
Control group
Active

Outcomes
Primary outcome [1] 293430 0
Diagnosis of pulmonary embolism classified as present, indeterminate or not present assessed with CTPA alone and with V/Q PET/CT alone.
Timepoint [1] 293430 0
Single time-point
Primary outcome [2] 293438 0
Diagnosis of pulmonary embolism classified as present, indeterminate or not present assessed with combined V/Q PET / CTPA
Timepoint [2] 293438 0
Single time-point
Secondary outcome [1] 311033 0
Detection of anomalies on CTPA only, V/Q PET/CT only, and both combined.
Timepoint [1] 311033 0
Single time-point

Eligibility
Key inclusion criteria
Patient with suspected acute pulmonary embolism
Patient has diagnosis of malignancy
Age greater than or equal to 18 years;
Written informed consent has been provided.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindication to contrast media (including renal insufficiency with eGFR<50)
Participant is not able to tolerate supine position for PET/CT acquisition, is not cooperative, or needs continuous nursing (e.g. patient from Intensive Care Unit).
Inability to perform CTPA and V/Q PET/CT within the 24 hours following the suspicion of PE.
Deep vein thrombosis or PE diagnosed within the previous 3 months
Use of therapeutic doses of parenteral anticoagulants for greater than 48 hours
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
Recruiting
Date of first participant enrolment
Anticipated
10/11/2014
Actual
17/11/2014
Date of last participant enrolment
Anticipated
31/03/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3074 0
Peter MacCallum Cancer Institute - East Melbourne

Funding & Sponsors
Funding source category [1] 290137 0
Self funded/Unfunded
Name [1] 290137 0
Physician sponsored
Country [1] 290137 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Center
Address
Peter MacCallum Cancer Institute
St Andrews Place
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 288847 0
None
Name [1] 288847 0
Address [1] 288847 0
Country [1] 288847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291843 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 291843 0
Peter MacCallum Cancer Centre
Ethics Committee Secretariat
Level 4, #10 St Andrews Place
East Melbourne Victoria 3002
Ethics committee country [1] 291843 0
Australia
Date submitted for ethics approval [1] 291843 0
Approval date [1] 291843 0
24/09/2014
Ethics approval number [1] 291843 0
14/117

Summary
Brief summary
The study is comparing two different techniques to diagnose acute pulmonary embolism 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 suspicion of acute pulmonary embolism.

What is the purpose of this research? Lung scan (also known as lung scintigraphy, ventilation/perfusion scan or V/Q scan) and CT pulmonary angiogram (called CTPA) are imaging tests that are used to diagnose pulmonary embolism (clots in the blood vessels supplying the lungs).
This research project is assessing the diagnostic value of a new imaging test called lung PET/CT. PET/CT stands for Positron Emission Tomography/Computed Tomography. The conventional lung scan uses a different technology called SPECT/CT (Single Photon Emission Tomography/Computed Tomography). PET/CT produces images of better quality than the conventional SPECT/CT scan, which may improve diagnosis of pulmonary embolism.

The research project is designed to compare the diagnostic value of lung PET/CT and CTPA for the diagnosis of pulmonary embolism. Our hypotheses are that V/Q PET/CT is an alternative modality to CTPA for diagnosis of PE and that the combination of both imaging may improve PE diagnosis.

What does participation in this research involve? You will undergo both CTPA and lung PET/CT scans. For the lung PET/CT scan, a small quantity of a substance called Galligas, which are particles labelled with a radioactive substance called Ga-68, is breathed in and thereby deposited into your lungs. After this, you will be required to lay still on the PET/CT camera bed for about 10 minutes whilst images are obtained. Whilst you are in the PET/CT scanner, you are then injected with a substance called Ga-MAA via the intravenous catheter. Ga-MAA stands for Ga-68 macroaggregated albumin (MAA) and is radioactive substance that localises in your lungs’ blood vessels. You will then be imaged again for a further 10 minutes. Lung PET/CT is a diagnostic procedure only, not a treatment.

Lung PET/CT and CTPA will be initially interpreted separately. CTPA and V/Q PET/CT images will then be interpreted together by a consensus reading.

It is anticipated that 50 patients will participate in this project.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52250 0
A/Prof Michael Hofman
Address 52250 0
Peter MacCallum Cancer Centre, St Andrews Place, East Melbourne VIC 3002
Country 52250 0
Australia
Phone 52250 0
+61396561852
Fax 52250 0
Email 52250 0
[email protected]
Contact person for public queries
Name 52251 0
A/Prof Michael Hofman
Address 52251 0
Peter MacCallum Cancer Centre, St Andrews Place, East Melbourne VIC 3002
Country 52251 0
Australia
Phone 52251 0
+61396561852
Fax 52251 0
Email 52251 0
[email protected]
Contact person for scientific queries
Name 52252 0
A/Prof Michael Hofman
Address 52252 0
Peter MacCallum Cancer Centre, St Andrews Place, East Melbourne VIC 3002
Country 52252 0
Australia
Phone 52252 0
+61396561852
Fax 52252 0
Email 52252 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
EmbaseIndependent and incremental value of ventilation/perfusion PET/CT and CT pulmonary angiography for pulmonary embolism diagnosis: results of the PECAN pilot study.2019https://dx.doi.org/10.1007/s00259-019-04338-z
N.B. These documents automatically identified may not have been verified by the study sponsor.