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Trial registered on ANZCTR


Registration number
ACTRN12609000089235
Ethics application status
Approved
Date submitted
14/01/2009
Date registered
10/02/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Investigation of the efficacy of single photon emission computed tomography (SPECT) ventilation/perfusion (V/Q) scintigraphy in diagnosing pulmonary embolism
Scientific title
An investigation of the sensitivity and specificity of single photon emission computed tomography (SPECT) ventilation/perfusion (V/Q) scintigraphy for the diagnosis of pulmonary embolism in 100 patients with suspected pulmonary embolism.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism 4276 0
Condition category
Condition code
Respiratory 4505 4505 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients to receive the following: One planar ventilation/perfusion (V/Q) scintigraphy using Technegas and 185MBq (5mCi) Tc-99m-Macro Aggregated Albumin (MAA) (Pulmolite CIS-US Inc Bedford MA USA) acquired on dual head Picker Prism 2000 (Cleveland Ohio) or Siemens eCam (Knoxville Tennessee) gamma cameras using low energy high-resolution collimators on the Tc-99m photopeak of 140kEv +/-10% for 60 stops 15 (10) seconds/stop 360 degrees; one SPECT ventilation/perfusion (V/Q) scintigraphy using Technegas and 185MBq (5mCi) Tc-99m-Macro Aggregated Albumin (MAA) (Pulmolite CIS-US Inc Bedford MA USA) acquired on dual head Picker Prism 2000 (Cleveland Ohio) or Siemens eCam (Knoxville Tennessee) gamma cameras using low energy high-resolution collimators on the Tc-99m photopeak of 140kEv +/-10% for 60 stops 15 (10) seconds/stop 360 degrees; one 16-row multidetector computed tomography pulmonary angiography (CTPA) extended from 1 cm above the aortic arch to the diaphragm, using contrast (120ml of Iomeron 300) injected intravenously at a rate of 3.5 ml/sec, and Philips MX8000 IDT model (Philips Healthcare Andover MA USA) or Toshiba Aquilion 16 model (Toshiba Minato-ku Tokyo, Japan) scanners operating with 16 times 0.75 mm collimation at pitch 0.9 and 0.5 second rotation and time and exposure factors of 120 kVp and 230 mA. with dose modulation software and automated bolus tracking software; Xray; d-dimer; respiratory physicians' diagnosis based on clinical measures and observations, Xray, CTPA, XDPVTE (d-dimer) and 3 month follow up. The information provided for the physicians' diagnosis specifically excludes the planar and SPECT ventilation/perfusion images and reports. Planar and SPECT ventilation and perfusion scintigraphy and CTPA are to be performed within 24 hours of each other, with the first scan commencing as soon as possible after recruitment, and the order of tests determined by the treating clinician. The scheduling and number of other diagnostic tests is also determined by the treating clinician, according to his/her clinical management plan. The physicians' diagnosis is separate from the treating clinician's diagnosis, and is reached at least three months after the completion of scans, and after retrospective review of the clinical information, CTPA scan report and three-month follow-up.
Intervention code [1] 4004 0
Diagnosis / Prognosis
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5288 0
Sensitivity and specificity of SPECT ventilation/perfusion (V/Q) scintigraphy, when compared with a respiratory physicians' diagnosis based on clinical measures and observations, Xray, computed tomography pulmonary angiography (CTPA), d-dimer and 3 month follow up.
Timepoint [1] 5288 0
Time of final diagnosis
Primary outcome [2] 5387 0
Agreement (proportion and Kappa) of SPECT ventilation/perfusion (V/Q) scintigraphy with diagnosis by computed tomography pulmonary angiography (CTPA)
Timepoint [2] 5387 0
At completion of scan reporting
Secondary outcome [1] 8897 0
Diagnostic quality of scans as assessed by two radiologists (in the case of computed tomography pulmonary angiography) or two nuclear medicine specialists (in the case of ventilation/perfusion scintigraphy) reporting the scans, who grade each scan as diagnostic or non-diagnostic. Discrepant gradings (one "diagnostic", one "non-diagnostic") were referred to a reference panel of three radiologists (in the case of computed tomography pulmonary angiography) or three nuclear medicine specialists (in the case of ventilation/perfusion scintigraphy) to reach a consensus decision.
Timepoint [1] 8897 0
At completion of scan reporting

Eligibility
Key inclusion criteria
Under investigation for presumed acute pulmonary embolism (PE), glomerular filtration rate above the lowest quartile for age group, ability to give informed consent, willingness to undergo all scans, screening completed before the scheduled time of first scan
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Critical illness
Current haemodynamic instability with shock or hypotension
Sustained ventricular tachycardia or ventricular fibrillation in the previous 24 hours
Myocardial infarction in the previous month, with ongoing instability
Chronic pulmonary hypertension
Renal impairment or on dialysis
Mechanical ventilatory support
Pregnancy
Allergy to intravenous contrast or iodine or lung scan agents
Severe thyroid disease
Previous pulmonary emboli
Inferior vena caval filter
Likelihood of receiving thrombolysis within 24 hours
Evidence of an alternative source of thromboemboli other than the pelvic veins and lower extremities
Institutionalised patient or prisoner
Likelihood of discharge before completion of study scans

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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4372 0
Hospital
Name [1] 4372 0
John Hunter Hospital
Country [1] 4372 0
Australia
Primary sponsor type
Individual
Name
Professor Michael Hensley
Address
The School of Medicine and Public Health,
University of Newcastle,
Callaghan, NSW, 2308
Australia

Hunter Region Mail Centre NSW 2310 Australia
Country
Australia
Secondary sponsor category [1] 3938 0
Individual
Name [1] 3938 0
Dr Barry Soans
Address [1] 3938 0
Clinical Director
Hunter New England Imaging,
Locked Bag 1,
Hunter Region Mail Centre, NSW, 2310,
Australia
Country [1] 3938 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6420 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 6420 0
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Australia
Ethics committee country [1] 6420 0
Australia
Date submitted for ethics approval [1] 6420 0
Approval date [1] 6420 0
05/11/2003
Ethics approval number [1] 6420 0
03/10/15/3.08

Summary
Brief summary
Pulmonary emboli (PE) are common and overlooking the diagnosis can result in serious harm and death. Various imaging modalities including ventilation-perfusion (V/Q) scanning and Computed Tomography Pulmonary Angiography (CTPA) are used. These imaging tests are imperfect and, even when combined with pretest stratification, often leave the clinician uncertain as to the presence or absence of PE.
Initial studies have suggested that Single Photon Emission Computed Tomography (SPECT) V/Q scintigraphy may be more sensitive and specific than planar V/Q scintigraphy, and have higher intra-observer reproducibility and fewer non-diagnostic studies. Studies also suggest that SPECT V/Q scintigraphy may be safer than CTPA for patients with contrast allergy and for young or pregnant women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35086 0
Address 35086 0
Country 35086 0
Phone 35086 0
Fax 35086 0
Email 35086 0
Contact person for public queries
Name 12433 0
Dr Susan Miles
Address 12433 0
Department of Medicine
Calvary Mater Newcastle
Locked Bag 7
Hunter Region Mail Centre NSW 2310 Australia
Country 12433 0
Australia
Phone 12433 0
+61 2 49211211
Fax 12433 0
Email 12433 0
Susan.Miles@mater.health.nsw.gov.au
Contact person for scientific queries
Name 3361 0
Professor Michael Hensley
Address 3361 0
The School of Medicine and Public Health,
University of Newcastle,
Callaghan, NSW, 2308
Australia
Country 3361 0
Australia
Phone 3361 0
+61 2 49217776
Fax 3361 0
Email 3361 0
Susan.Miles@mater.health.nsw.gov.au

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
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