Safety and Efficacy Assessment of Diagnostic Microprobe (... | NCT05415943

NCT05415943

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women at high risk of breast cancer	Experimental	Women with a confirmed diagnosis of breast cancer by thick-needle biopsy and known HER2 receptor expression status, referred for surgical treatment.	Device: Diagnostic microprobe (inPROBE) medical device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diagnostic microprobe (inPROBE) medical device	Device	Introduction of the inPROBE microprobe (two simultaneous punctures) into the breast as a procedure prior to surgical resection of tumors with known HER2 receptor status.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Preliminary determination of HER2 receptor concentration ranges detected with inPROBE corresponding to HER2 receptor status (positive/negative) as determined by current diagnostic standard (IHC/FISH).		Day 1

Secondary Outcomes

Measure	Description	Time Frame
The occurrence of defects, failures, and fractures of the inPROBE probe during the diagnostic procedure leading to AE/ SAE.		Day 1 - Day 14
Comparison of the correlation of HER2 receptor concentrations detected by the inPROBE probe located in the tumor and in the immediate tumor area in HER2 positive patients.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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;