Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000348459
Ethics application status
Approved
Date submitted
8/04/2025
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a Heart Ultrasound Help Predict the Need for Major Vein Replacement in Cancer Surgery?
Scientific title
Can Intracardiac Echocardiography Catheter IVUS assessment of inferior vena cava / retroperitoneal tumour interface predict the need for caval replacement and ECMO during tumour resection in patients with tumours that compress or involve the IVC?
Secondary ID [1] 314106 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcoma - soft tissue 336892 0
Condition category
Condition code
Cancer 333363 333363 0 0
Sarcoma (also see 'Bone') - soft tissue
Surgery 333531 333531 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-operative intravenous ultrasound (IVUS) scanning using intracardiac echography (ICE) of the inferior vena cava (IVC) to assess tumour invasion from tumour compression in patients with large right sided retroperitoneal sarcomas with Computed Tomography and or Magnetic Resonance Imaging suggestive of IVC involvement.

The IVUS procedure is a day case procedure and will be performed under local anaesthesia with or without light sedation by a Specialist Interventional Radiologist. The procedure involves passing a 8-10F ICE catheter into the IVC either via the femoral veins or internal jugular veins. The ICE catheter will be advances to the area of interest to assess if the tumour is involving the IVC or only compressing due to mass effect. The duration of the ICE procedure is approximately 30-45 minutes. A draft report will be created but not published until after the surgery. The primary surgeons, who will be assessing involvement/compression at the time of surgery will be blinded to the results of the ICE procedure.
Intervention code [1] 330679 0
Early detection / Screening
Comparator / control treatment
This is a prospective blinded diagnostic accuracy study with no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340939 0
The primary outcome of this study is to assess the accuracy of ICE in distinguishing tumour infiltration of the IVC from tumour compression on pre-operative screening.
Timepoint [1] 340939 0
The intervention will be performed in the immediate 2-4 weeks pre-tumour resection. Results on the ICE assessment will remain blinded to the surgeons. Intraoperative findings (reference variable) will assessed at the time of surgery.
Secondary outcome [1] 445536 0
Secondary outcomes include evaluating the safety profile of ICE catheters and monitoring the incidence of adverse events associated with their use, such as vessel perforation, groin haematoma, bleeding, infection, thrombosis, pseudoaneurysm, arrhythmia, transfusion, or arteriovenous fistula
Timepoint [1] 445536 0
At the time of intervention and at the time of surgical resection.

Eligibility
Key inclusion criteria
Patients with right sided retroperitoneal soft tissue sarcoma with computerised tomography (CT) or magnetic resonance imaging (MRI) demonstrating compression or involvement of the IVC
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient without any imaging suggestive of IVC compression or tumour infiltration
Patients not suitable for open surgical resection of tumour
Patients without adequate venous access for ICE imaging
Patients with known presence of deep vein thrombosis
Patients with poor spoken and/or written English language comprehension
Pregnancy

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intraoperative surgical findings serving as the reference standard. To assess the agreement between ICE and surgical assessment, McNemar’s test will be performed to determine whether there is a statistically significant difference in the misclassification rates of compression versus invasion. Additionally, diagnostic accuracy testing will be performed using the rest and reference variables above and will include sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) calculations to quantify the performance of ICE in detecting vascular invasion. Given the small sample size, Fisher’s exact test will be used to assess significance where applicable, and 95% confidence intervals for diagnostic metrics will be estimated. This analysis will provide preliminary evidence on the utility of ICE in differentiating vascular compression from invasion, informing future studies with larger cohorts.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
20/12/2026
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27733 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 43922 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 318612 0
Hospital
Name [1] 318612 0
Sir Charles Gairdner Hospital - Department of Radiology
Country [1] 318612 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Country
Australia
Secondary sponsor category [1] 321106 0
None
Name [1] 321106 0
Address [1] 321106 0
Country [1] 321106 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317216 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 317216 0
Ethics committee country [1] 317216 0
Australia
Date submitted for ethics approval [1] 317216 0
06/06/2023
Approval date [1] 317216 0
10/10/2023
Ethics approval number [1] 317216 0
RGS0000006121

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140374 0
Dr James Preuss
Address 140374 0
Department of Anaesthesia, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands, Western Australia, 6008
Country 140374 0
Australia
Phone 140374 0
+61 8 64572358
Fax 140374 0
Email 140374 0
[email protected]
Contact person for public queries
Name 140375 0
James Preuss
Address 140375 0
Department of Anaesthesia, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands, Western Australia, 6008
Country 140375 0
Australia
Phone 140375 0
+61 8 64572358
Fax 140375 0
Email 140375 0
[email protected]
Contact person for scientific queries
Name 140376 0
James Preuss
Address 140376 0
Department of Anaesthesia, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands, Western Australia, 6008
Country 140376 0
Australia
Phone 140376 0
+61 8 64572358
Fax 140376 0
Email 140376 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.