None listed
Conditions
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 or mastectomy 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 or mastectomy 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.
Interventions
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
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.
This study will investigate quantitative microelastography imaging of ex vivo breast tissue by scanning fresh specimens from breast conserving or mastecomty 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 or mastectomy surgery, as per surgical standard of care/clinical decisi
This study will investigate quantitative microelastography imaging of ex vivo breast tissue by scanning fresh specimens from breast conserving or mastecomty 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 or mastectomy 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.
Sponsors
OncoRes Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
Exclusion criteria
None
Outcome results
None listed