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Trial registered on ANZCTR
Registration number
ACTRN12624001425583
Ethics application status
Approved
Date submitted
8/11/2024
Date registered
5/12/2024
Date last updated
4/06/2025
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.
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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.
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Secondary ID [1]
313340
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None
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Universal Trial Number (UTN)
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Trial acronym
NEXUS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
335696
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Condition category
Condition code
Cancer
332259
332259
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0
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Breast
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329924
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Treatment: Devices
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Intervention code [2]
329922
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Treatment: Surgery
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Intervention code [3]
329925
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Diagnosis / Prognosis
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Comparator / control treatment
Histopathology slide images will be used as a the gold standard reference comparator for this study.
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Control group
Active
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Outcomes
Primary outcome [1]
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Breast cancer quantitative micro-electrography validity.
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Assessment method [1]
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Acquire a dataset of co-registered ex vivo images of breast tissue from 30 patients by scanning freshly excised specimens. Scan images will be co-registered with histology images to determine tissue types present in each scan.
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Timepoint [1]
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End of study.
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Secondary outcome [1]
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na
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Assessment method [1]
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na
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Timepoint [1]
441569
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na
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
None
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
2/05/2025
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Actual
5/05/2025
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Date of last participant enrolment
Anticipated
30/06/2025
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
30
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Accrual to date
8
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
317788
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Commercial sector/Industry
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Name [1]
317788
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OncoRes Medical Pty Ltd
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Address [1]
317788
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Country [1]
317788
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
OncoRes Medical Pty Ltd
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Address
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Country
Australia
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Secondary sponsor category [1]
320107
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None
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Name [1]
320107
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Address [1]
320107
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Country [1]
320107
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316471
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South Metropolitan Health Service Human Research Ethics Committee
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Ethics committee address [1]
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https://smhs.health.wa.gov.au/Our-research/For-researchers
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Ethics committee country [1]
316471
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Australia
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Date submitted for ethics approval [1]
316471
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29/10/2024
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Approval date [1]
316471
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11/02/2025
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Ethics approval number [1]
316471
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Summary
Brief summary
The purpose of this study is to develop a dataset of micro-elastography images co-registered to ex vivo images of breast tissue. Who is it for? You may be eligible for this study if you are a woman aged 18 years or older, you have been diagnosed with invasive or in situ carcinoma and you are eligible for breast conserving surgery based on clinical evaluation by the Investigator. Study details The images will be acquired from fresh breast specimens using the ORM-P2 system - a new handheld imaging device being developed for margin assessment using micro-elastography during breast conserving surgery. Participants undergoing breast conserving surgery who consent to the study will have their fresh breast specimens collected from theatre and scanned using the ORM-P2 investigational device, prior to routine pathology testing. It is hoped this research will determine whether use of the ORM-P2 device is effective at developing a dataset of co-registered quantitative micro-elastography ex vivo images of breast tissue.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Saud Hamza
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Address
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Fiona Stanley Hospital Breast Cancer Centre 11 Robin Warren Drive MURDOCH WA 6150
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Country
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Australia
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Phone
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+61 08 6148 0540
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
137999
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Saud Hamza
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Address
137999
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Fiona Stanley Hospital Breast Cancer Centre 11 Robin Warren Drive MURDOCH WA 6150
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Country
137999
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Australia
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Phone
137999
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+61 08 6148 0540
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Fax
137999
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Email
137999
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[email protected]
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Contact person for scientific queries
Name
138000
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Saud Hamza
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Address
138000
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Fiona Stanley Hospital Breast Cancer Centre 11 Robin Warren Drive MURDOCH WA 6150
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Country
138000
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Australia
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Phone
138000
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+61 08 6148 0540
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Fax
138000
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Email
138000
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[email protected]
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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.
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