Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001132538p
Ethics application status
Submitted, not yet approved
Date submitted
28/08/2024
Date registered
19/09/2024
Date last updated
19/09/2024
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
An adaptive, multi-centre, prospective, single arm cohort 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 handheld optical imaging system for intra-operative use during Breast Conserving Surgery (BCS) used by the surgeon and viewed on a screen during surgery.

The investigator (breast surgeon) will undergo a 1 hour face-to-face training session with OncoRes Medical Pty Ltd on the use of the ORM-P3-D system, at least a month before commencement of intervention. The training involves handling of the device with a phantom model, interpretation of images and review of precautions, warning and contraindications.

Participants will undergo standard of care breast conserving surgery (1-2 hour 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. Adherence to the study protocol during intervention will be supervised by a member of the site research team and recorded as an electronic case report form in the trial database.

Participants will take part in 3-4 study visits over 5 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] 329339 0
Treatment: Surgery
Intervention code [2] 329483 0
Diagnosis / Prognosis
Intervention code [3] 329484 0
Treatment: Devices
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 shavings 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
To evaluate the diagnostic accuracy of the ORM- P3-D system compared to standard of care (SOC) in detecting residual cancer in the surgical cavity during breast conserving surgery (BCS).
Timepoint [1] 339170 0
End of study.
Primary outcome [2] 339171 0
To evaluate the safety of the ORM-P3-D system for use during breast conserving surgery.
Timepoint [2] 339171 0
End of study visit.
Primary outcome [3] 339184 0
Number of participants with complete set of pathology reports received.
Timepoint [3] 339184 0
After 60 patients have completed their 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] 438906 0
Evaluation of BREAST-Q patient survey 4 domains: psychosocial wellbeing, sexual wellbeing, satisfaction with breasts and satisfaction with outcome and Participant Survey. This will be assessed as a composite outcome.
Timepoint [2] 438906 0
End of study visit.
Secondary outcome [3] 438907 0
To assess pain scores following investigational device use.
Timepoint [3] 438907 0
End of study visit.

Eligibility
Key inclusion criteria
1. Participants willing to provide written informed consent
2. Female, 18 years of age and over
3. Histologically confirmed invasive or in situ carcinoma
4. Candidate for breast conserving surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has any condition that, in the Investigator’s opinion, would preclude the use of the investigational medical device, may interfere with the evaluation of the investigational medical device or breast related outcomes or preclude the participant from completing the follow up visits.
2. Have an active implanted stimulation device (i.e., implanted, defibrillator or pacemaker, deep brain stimulator, spinal cord stimulator).
3. Be unwilling to comply with all investigational requirements.

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
3/02/2025
Actual
Date of last participant enrolment
Anticipated
2/02/2026
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC

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
Submitted, not yet 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
Ethics approval number [1] 315970 0

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

Contacts
Principal investigator
Name 136378 0
Prof Christobel Saunders
Address 136378 0
James Stewart Chair of Surgery University of Melbourne Department of Surgery The Royal Melbourne Hospital Grattan Street PARKVILLE VIC 3050 Australia
Country 136378 0
Australia
Phone 136378 0
+61 3 8344 2033
Fax 136378 0
Email 136378 0
[email protected]
Contact person for public queries
Name 136379 0
Prof Christobel Saunders
Address 136379 0
James Stewart Chair of Surgery University of Melbourne Department of Surgery The Royal Melbourne Hospital Grattan Street PARKVILLE VIC 3050 Australia
Country 136379 0
Australia
Phone 136379 0
+61 3 8344 2033
Fax 136379 0
Email 136379 0
[email protected]
Contact person for scientific queries
Name 136380 0
Prof Christobel Saunders
Address 136380 0
James Stewart Chair of Surgery University of Melbourne Department of Surgery The Royal Melbourne Hospital Grattan Street PARKVILLE VIC 3050 Australia
Country 136380 0
Australia
Phone 136380 0
+61 3 8344 2033
Fax 136380 0
Email 136380 0
[email protected]

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.