Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001425583p
Ethics application status
Submitted, not yet approved
Date submitted
8/11/2024
Date registered
5/12/2024
Date last updated
5/12/2024
Date data sharing statement initially provided
5/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-centre, prospective study for investigation of ex vivo quantitative
micro-elastography images acquired from breast tissue.
Scientific title
A multi-centre, prospective study for investigation of ex vivo quantitative
micro-elastography images acquired from breast tissue in women with histologically confirmed invasive or in situ carcinoma.
Secondary ID [1] 313340 0
None
Universal Trial Number (UTN)
Trial acronym
NEXUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 335696 0
Condition category
Condition code
Cancer 332259 332259 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate quantitative microelastography imaging of ex vivo breast tissue by scanning fresh specimens from breast conserving surgery using the ORM-P2 device; a new handheld imaging device being developed for margin assessment using quantitative micro-elastography during breast conserving surgery.

Fresh main and additional margin specimens removed from participants undergoing breast conserving surgery, as per surgical standard of care/clinical decision making.

Excised specimen's will be scanned by engineers using the ORM-P2 device for a maximum of 1 hour from time of excision, before being placed in formalin. Engineers operating the device will be provided with face to face training a minimum of 2 weeks prior to first participant enrollment.

The specimens will undergo routine pathological testing, and scans will be co-registered with histology slide images.
Intervention code [1] 329922 0
Treatment: Surgery
Intervention code [2] 329924 0
Treatment: Devices
Intervention code [3] 329925 0
Diagnosis / Prognosis
Comparator / control treatment
Histopathology slide images will be used as a the gold standard reference comparator for this study.
Control group
Active

Outcomes
Primary outcome [1] 339831 0
Breast cancer quantitative micro-electrography validity.
Timepoint [1] 339831 0
End of study.
Secondary outcome [1] 441569 0
na
Timepoint [1] 441569 0
na

Eligibility
Key inclusion criteria
1. Participant is capable of understanding, and willing to provide written informed consent.
2. Female, over 18 years of age.
3. Histologically confirmed invasive or in situ carcinoma.
4. Candidate for breast conserving surgery based on clinical evaluation by the Investigator.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317788 0
Commercial sector/Industry
Name [1] 317788 0
OncoRes Medical Pty Ltd
Country [1] 317788 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
OncoRes Medical Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320107 0
None
Name [1] 320107 0
Address [1] 320107 0
Country [1] 320107 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316471 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 316471 0
Ethics committee country [1] 316471 0
Australia
Date submitted for ethics approval [1] 316471 0
29/10/2024
Approval date [1] 316471 0
Ethics approval number [1] 316471 0

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

Contacts
Principal investigator
Name 137998 0
Mr Saud Hamza
Address 137998 0
Fiona Stanley Hospital Breast Cancer Centre 11 Robin Warren Drive MURDOCH WA 6150
Country 137998 0
Australia
Phone 137998 0
+61 08 6148 0540
Fax 137998 0
Email 137998 0
Saud.Hamza@health.wa.gov.au
Contact person for public queries
Name 137999 0
Saud Hamza
Address 137999 0
Fiona Stanley Hospital Breast Cancer Centre 11 Robin Warren Drive MURDOCH WA 6150
Country 137999 0
Australia
Phone 137999 0
+61 08 6148 0540
Fax 137999 0
Email 137999 0
Saud.Hamza@health.wa.gov.au
Contact person for scientific queries
Name 138000 0
Saud Hamza
Address 138000 0
Fiona Stanley Hospital Breast Cancer Centre 11 Robin Warren Drive MURDOCH WA 6150
Country 138000 0
Australia
Phone 138000 0
+61 08 6148 0540
Fax 138000 0
Email 138000 0
Saud.Hamza@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.