None listed
Conditions
Brief summary
The research project is testing a new imaging device for use during breast conserving surgery, involving the use of a medical device called ORM-P3-D System. The purpose of this study is to find out the diagnostic accuracy and safety of the ORM-P3-D 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 22 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 3-4 study visits scheduled over a 6 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-P3-D medical device. During the surgery, the surgeon will use the device to scan the breast tissue and take additional tissue if indicated by the device. After the surgery, participants will be asked to attend a final study visit where a surgical review and adverse event assessment will be undertaken.
Interventions
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 investi
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.
Sponsors
OncoRes Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver)
Eligibility
Sex/Gender
All
Age
22 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
1. Pregnancy. 2. Lactation. 3. Prior ipsilateral breast surgery including breast-conserving surgery, mastectomy, reconstruction or implants. 4. Prior ipsilateral breast radiation. 5. Systemic infections or infections at the site of surgery at the time of surgery. 6. Level 2, or above, Oncoplastic techniques are planned for their breast conserving surgery. 7. Participants who have received neoadjuvant chemotherapy prior to surgery, or are still undergoing chemotherapy treatment at the time of breast conserving surgery. 8. 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.
Outcome results
None listed