Safety and Efficacy Assessment of Diagnostic Microprobe (inPROBE) in Women at High Risk of Breast Cancer (Part I Study)

NCT05415943 | Completed

• 1 other identifier: SDS-HER-01-2018
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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 (IHC/FISH), in women with both HER2-positive and HER2-negative breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• 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.

  Day 1

Study Arms (1)

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

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.

Women at high risk of breast cancer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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;

Sponsors & Collaborators

• SDS Optic S.A.: lead

Study Sites (2)

Uniwersyteckie Centrum Leczenia Chorób Piersi, Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

Location

Klinika Chirurgii Onkologicznej

Lublin, 20-081, Poland

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 13, 2022
• Study Start: August 24, 2022
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

PL (2)