Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001132538
Ethics application status
Approved
Date submitted
28/08/2024
Date registered
19/09/2024
Date last updated
12/06/2025
Date data sharing statement initially provided
19/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-centre clinical trial evaluating the diagnostic accuracy and safety of a medical imaging device in identifying cancer during breast-conserving surgery.
Scientific title
A multi-centre, prospective, single arm study, evaluating the diagnostic accuracy and safety of the ORM-P3-D System in identifying residual cancer within the surgical cavity during breast-conserving surgery.
Secondary ID [1] 312799 0
None
Universal Trial Number (UTN)
Trial acronym
MARGIN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 334863 0
Condition category
Condition code
Cancer 331420 331420 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will assess the diagnostic accuracy and safety of the ORM-P3-D System.
The ORM-P3-D System is a diagnostic imaging system for the identification of residual cancerous tissue within the breast-conserving surgery (BCS) cavity after the main specimen is removed and is indicated for intra-operative use by surgeons in patients undergoing BCS for previously diagnosed breast cancer. ORM-P3-D is also indicated for excised tissue to identify cancerous tissue on the specimen edge.

The investigator (breast surgeon) will undergo a face-to-face training session with OncoRes Medical Pty Ltd on the use of the ORM-P3-D system, before commencement of intervention. The training involves handling of the device with a phantom model, interpretation of images and review of precautions, warnings and contraindications.

Participants will undergo standard of care breast conserving surgery for breast cancer. During the surgery the investigational medical device will be used to guide the excision of tissue by measuring optical and mechanical properties of the tissue.
Following the excision and orientation of the main specimen, as per standard of care, handheld scans of the main specimen and surgical cavity will be performed using the investigational medical device, ORM-P3-D, to determine whether residual tumour can be visualised in the breast cavity and on the excised tissue. As excised main specimen scanning will occur prior to intraoperative x-ray, the surgeon will be blinded to the diagnostic imaging results that may bias SOC nominated shavings.

Adherence to the study protocol during intervention will be supervised by a member of the site research team and data will be recorded in an electronic case report form in the trial database.

Participants will take part in 3-4 study visits over 6 months. At the end of the trial participants will continue to receive standard of care treatment for their condition at the Institution.
Intervention code [1] 329484 0
Treatment: Devices
Intervention code [2] 329483 0
Diagnosis / Prognosis
Intervention code [3] 329339 0
Treatment: Surgery
Comparator / control treatment
There are no control participants in this study, however diagnostic accuracy of the device will be compared against:
1) Standard of care initiated specimens during index procedure. Surgeons will use clinical judgment to determine which cavity margins will be shaved and inform the study personnel for recording in the study database, prior to device use.
2) Histopathology assessment. Study images acquired will be compared with routine histology of shavings to assess the primary and secondary outcome measures.
Control group
Active

Outcomes
Primary outcome [1] 339170 0
Equivalent or higher diagnostic accuracy compared to standard of care assessment of the surgical cavity.
Timepoint [1] 339170 0
End of study.
Primary outcome [2] 339171 0
Adverse events and serious adverse events stratified by severity and relatedness to device.
Timepoint [2] 339171 0
End of study visit.
Secondary outcome [1] 438905 0
Diagnostic accuracy compared to histopathology assessment of the shaving.
Timepoint [1] 438905 0
End of study.
Secondary outcome [2] 448697 0
Exploratory: Rate of positive margins following index procedure.
Timepoint [2] 448697 0
End of study
Secondary outcome [3] 438906 0
Diagnostic accuracy compared to histopathology assessment of the main specimen.
Timepoint [3] 438906 0
End of study visit.
Secondary outcome [4] 448698 0
Evaluation of BREAST-Q patient survey satisfaction with breasts and Participant Survey.
Timepoint [4] 448698 0
End of study visit
Secondary outcome [5] 448696 0
Exploratory: Rate of re-excision at follow-up visit
Timepoint [5] 448696 0
Follow up visit (Day 7 +60)

Eligibility
Key inclusion criteria
1. Female adult aged 22 years and older.
2. Histologically confirmed invasive or in situ carcinoma confirmed by core needle biopsy or fine needle biopsy.
3.Candidate for breast conserving surgery.
4.Willing and able to provide written and informed consent.
5.Willing and able to comply with study procedures and follow-up.
Minimum age
22 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy.
2. Lactation.
3. Prior ipsilateral breast surgery including breast-conserving surgery, mastectomy, reconstruction or implants.
4. Prior breast radiation.
5. Systemic infections or infections at the site of surgery at the time of surgery.
6. Has any condition, that in the investigator's opinion, would preclude the use of the study device, may interfere with the evaluation of the device or preclude the participant from completing the follow-up visits.

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

The people administering the treatment/s

Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A paired diagnostic test design (both diagnostic tests are performed on each subject) will be used to test the sensitivity of diagnostic test 1 (Device) against the sensitivity of diagnostic test 2 (Standard of Care). The comparison will be made using a one-sided McNemar test with a Type I error rate (a) of 0.05. The prevalence of the condition/disease in the population is assumed to be 20%, and the proportion of discordant pairs is assumed to be 0.5. To detect a sensitivity difference of 0.4 (test 1 sensitivity: 90%, test 2 sensitivity: 50%) with 80% power, the number of needed shavings is 105. The sample size was computed using PASS 2023, version 23.0.1.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2025
Actual
Date of last participant enrolment
Anticipated
2/02/2026
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
135
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment hospital [1] 28041 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 28040 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 28042 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 28043 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [5] 28045 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [6] 28044 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 44245 0
3000 - Melbourne
Recruitment postcode(s) [2] 44246 0
3050 - Parkville
Recruitment postcode(s) [3] 44247 0
6160 - Fremantle
Recruitment postcode(s) [4] 44244 0
6150 - Murdoch
Recruitment postcode(s) [5] 44249 0
6008 - Subiaco
Recruitment postcode(s) [6] 44248 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 317232 0
Commercial sector/Industry
Name [1] 317232 0
OncoRes Medical Pty Ltd
Country [1] 317232 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
OncoRes Medical Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319514 0
None
Name [1] 319514 0
Address [1] 319514 0
Country [1] 319514 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315970 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 315970 0
Ethics committee country [1] 315970 0
Australia
Date submitted for ethics approval [1] 315970 0
27/08/2024
Approval date [1] 315970 0
28/11/2024
Ethics approval number [1] 315970 0

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

Contacts
Principal investigator
Name 136378 0
Dr David Speakman
Address 136378 0
Executive Director Clinical Services Peter MacCallum Cancer Centre 305 Grattan Street PARKVILLE VIC 3000
Country 136378 0
Australia
Phone 136378 0
+61 3 85595114
Fax 136378 0
Email 136378 0
[email protected]
Contact person for public queries
Name 136379 0
Dr Bridget Ryan
Address 136379 0
OncoRes Medical 24 Leura Street, Nedlands Western Australia 6009
Country 136379 0
Australia
Phone 136379 0
+61 08 6389 0210
Fax 136379 0
Email 136379 0
[email protected]
Contact person for scientific queries
Name 136380 0
Dr Bridget Ryan
Address 136380 0
OncoRes Medical 24 Leura Street, Nedlands Western Australia 6009
Country 136380 0
Australia
Phone 136380 0
+61 08 6389 0210
Fax 136380 0
Email 136380 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.