Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000205639
Ethics application status
Approved
Date submitted
21/11/2022
Date registered
27/02/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
27/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-centre clinical trial evaluating the safety and functionality of a medical imaging device for tissue review during breast-conserving surgery.
Scientific title
A multi-centre clinical trial study evaluating the safety and functionality of the ORM-P2 System for differentiating tissue types in the resection bed during breast-conserving surgery.
Secondary ID [1] 308511 0
None
Universal Trial Number (UTN)
Trial acronym
OPTICS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 328264 0
Condition category
Condition code
Cancer 325308 325308 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will assess the safety and functionality of the ORM-P2 System. The ORM-P2 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. Surgeons will be trained in the use of the device by OncoRes Medical Pty Ltd on the intended use, precautions, scanning protocol and contraindication in the use of the device.
Participants will undergo standard of care breast conserving surgery for breast cancer (approx. 30 to 45 min duration). During the surgery the investigational medical device will be used, adding 5-10 min to standard of care surgery, to guide the excision of tissue by measuring properties of the tissue.

Participants will take part in 3 study visits (duration of 1-2 hrs per visit) over 4 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] 324903 0
Treatment: Surgery
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333173 0
To evaluate the safety of the use of the ORM-P2 System for the duration of the device use.
Adverse events will be assessed during and after the surgical procedure, as well as at the follow up visit (end of study visit) on day 7 post op by clinical examination by the Investigator.
Timepoint [1] 333173 0
Device related serious adverse events which result in death or permanent disability during the follow up period from surgery/index procedure, immediately post operatively to discharge and at the surgical post operative review (end of study visit).
Secondary outcome [1] 416051 0
To evaluate the differentiated tissue assessment for the detection of tissue with elevated stiffness in the resection bed during breast conserving surgery (Sensitivity and specificity of the differentiated tissue)
Timepoint [1] 416051 0
At end of study, during data analysis.
Secondary outcome [2] 418767 0
Histological assessment of excised tissue will be conducted post operatively as per standard of care.
Timepoint [2] 418767 0
4 weeks post operatively

Eligibility
Key inclusion criteria
Female
Histologically confirmed invasive or in situ carcinoma
Candidate for breast conserving surgery based on clinical and radiological evaluation by
the Investigator
Participant is capable of understanding, and willing to provide, written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant, lactating or planning to become pregnant during the study
Systemic infection or infection at the surgical site of the time of surgery.
Nicotine user not having quit at least four weeks prior to surgery
Any medical condition such as insulin dependent diabetes, chronic lung or severe
cardiovascular disease that might, in the opinion of the Investigator, result in unduly high
surgical risk and/or significant postoperative complications.
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.
Have an active implanted stimulation device (i.e., implanted, defibrillator or pacemaker,
deep brain stimulator, spinal cord stimulator).
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
open label
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Descriptive summaries of categorical variables will include # and %. Descriptive summaries for continuous variables will include means, median, SD, min and max values.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2023
Actual
7/12/2023
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
30
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
WA,VIC
Recruitment hospital [1] 23615 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 23617 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 23618 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 24444 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 39037 0
3000 - Melbourne
Recruitment postcode(s) [2] 39036 0
3050 - Parkville
Recruitment postcode(s) [3] 39034 0
6150 - Murdoch
Recruitment postcode(s) [4] 40025 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 312703 0
Commercial sector/Industry
Name [1] 312703 0
OncoRes Medical Pty Ltd
Country [1] 312703 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
OncoRes Medical Pty Ltd
Address
Suite 5
24 Leura Street
Nedlands
WA 6009
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 314321 0
None
Name [1] 314321 0
Address [1] 314321 0
Country [1] 314321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312003 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 312003 0
South Metropolitan Health Service Executive
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH Western Australia 6150
Ethics committee country [1] 312003 0
Australia
Date submitted for ethics approval [1] 312003 0
29/11/2022
Approval date [1] 312003 0
23/02/2023
Ethics approval number [1] 312003 0

Summary
Brief summary
The research project is testing a new imaging/treatment device for use during breast conserving surgery, involving the use of a medical device called ORM-P2 System. The purpose of this study is to find out if it is safe to use the ORM-P2 System during breast conserving surgery for patients with breast cancer.

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 breast cancer and you are eligible to undergo breast conserving surgery as part of your cancer treatment.

Study details
All participants who choose to enrol in this study will be asked to attend three study visits scheduled over a 4 month period. The first visit will be a screening visit to determine whether you are eligible to enrol in the study. Those participants who are eligible to enrol will continue with their standard cancer care and will be scheduled for a breast conserving surgery. The surgery will be undertaken per standard protocols, with the addition of the ORM-P2 medical device. During the surgery, a clinician will use the device to scan the breast tissue. The device will provide images on the tissue's optical and mechanical properties on a micro-scale. Use of the device is anticipated to add 5 to 10 minutes to the overall surgery time. At 4 weeks after the surgery, participants will be asked to attend a final study visit where a surgical review and adverse event assessment will be undertaken.

It is hoped this research will determine whether use of the ORM-P2 System is effective at differentiating tissue types remaining in the surgical cavity.
Trial website
Trial related presentations / publications
Public notes
Reimbursement for any reasonable travel/parking (up to $100) and meals (up to $30) per visit associated will be given for each research project visit.

Contacts
Principal investigator
Name 123138 0
Prof Christobel Saunders
Address 123138 0
James Stewart Chair of Surgery University of Melbourne
Department of Surgery
The Royal Melbourne Hospital
Grattan Street
PARKVILLE VIC 3050
Australia
Country 123138 0
Australia
Phone 123138 0
+61 3 8344 2033
Fax 123138 0
Email 123138 0
christobel.saunders@mh.org.au
Contact person for public queries
Name 123139 0
Prof Christobel Saunders
Address 123139 0
James Stewart Chair of Surgery University of Melbourne
Department of Surgery
The Royal Melbourne Hospital
Grattan Street
PARKVILLE VIC 3050
Australia
Country 123139 0
Australia
Phone 123139 0
+61 3 8344 2033
Fax 123139 0
Email 123139 0
christobel.saunders@mh.org.au
Contact person for scientific queries
Name 123140 0
Prof Christobel Saunders
Address 123140 0
James Stewart Chair of Surgery University of Melbourne
Department of Surgery
The Royal Melbourne Hospital
Grattan Street
PARKVILLE VIC 3050
Australia
Country 123140 0
Australia
Phone 123140 0
+61 3 8344 2033
Fax 123140 0
Email 123140 0
christobel.saunders@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At this point in time, the IPD will not be shared.
This may change during the trial's recruitment/ analysis stage.


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.