Status:
COMPLETED
Safety and Efficacy Assessment of Diagnostic Microprobe (inPROBE) in Women at High Risk of Breast Cancer (Part I Study)
Lead Sponsor:
SDS Optic S.A.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to preliminarily determine the correlation of HER2 receptor levels detected with the inPROBE diagnostic probe relative to receptor status as determined by standard methods...
Eligibility Criteria
Inclusion
- Provision of written informed consent to participate in the clinical investigation;
- Female patient aged ≥ 18 to ≤ 75 years;
- The patient's overall health status as determined by Eastern Cooperative Oncology Group (ECOG) from 0 to 1;
- Preserved full ability to communicate with the investigator and to understand and comply with the requirements of the Clinical investigation plan;
- High likelihood of attending follow-up appointments in accordance with the study design and completing this study in accordance with this Clinical investigation plan.
- The presence of a malignant neoplasm (breast cancer) confirmed by histopathologic examination of material from a gross needle biopsy of the tumor, with specific HER2 receptor status.
- Patient referred for surgical treatment of breast cancer.
Exclusion
- History of treatment with trastuzumab, or other HER 2 receptor-binding antibody, as part of neoadjuvant (induction) therapy for currently diagnosed and treated breast cancer.
- A skin disorder that prevents or contraindicates to perform a probe examination in the opinion of the investigator;
- Breast inflammation/infection on the day of the probe examination;
- Allergy to any component of the medical device that is the subject of this clinical investigation;
- An implant in the breast where the inPROBE study and surgery will be performed;
- Any physical or psychiatric condition, or laboratory test values outside the normal range, which in the opinion of the investigator constitute a contraindication to the patient's participation in this clinical investigation or pose a risk of exclusion from the study or premature termination of participation in the study;
- Any clinically significant abnormality in physical examination, vital signs, or laboratory tests that, in the opinion of the investigator, is a contraindication to participation in this clinical trial;
- Pregnancy or breastfeeding;
- Participation in another clinical trial within 30 days prior to signing informed consent to participate in this clinical investigation;
Key Trial Info
Start Date :
August 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05415943
Start Date
August 24 2022
End Date
March 2 2023
Last Update
July 27 2023
Active Locations (2)
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1
Uniwersyteckie Centrum Leczenia Chorób Piersi, Szpital Uniwersytecki w Krakowie
Krakow, Poland, 30-688
2
Klinika Chirurgii Onkologicznej
Lublin, Poland, 20-081