We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05415943
Recruitment Status : Recruiting
First Posted : June 13, 2022
Last Update Posted : September 1, 2022
Sponsor:
Information provided by (Responsible Party):
SDS Optic S.A.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Diagnostic microprobe (inPROBE) medical device Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Open-label, Multicentre, Single-arm Safety and Efficacy Clinical Investigation of Diagnostic Microprobe (inPROBE) for the Assessment of HER2 Receptor Expression in Population of Women at High Risk of Breast Cancer
Actual Study Start Date : August 24, 2022
Estimated Primary Completion Date : September 23, 2022
Estimated Study Completion Date : September 23, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Women at high risk of breast cancer
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
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.




Primary Outcome Measures :
  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). [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. The occurrence of defects, failures, and fractures of the inPROBE probe during the diagnostic procedure leading to AE/ SAE. [ Time Frame: Day 1 - Day 14 ]
  2. 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. [ Time Frame: Day 1 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of written informed consent to participate in the clinical investigation;
  2. Female patient aged ≥ 18 to ≤ 75 years;
  3. The patient's overall health status as determined by Eastern Cooperative Oncology Group (ECOG) from 0 to 1;
  4. Preserved full ability to communicate with the investigator and to understand and comply with the requirements of the Clinical investigation plan;
  5. High likelihood of attending follow-up appointments in accordance with the study design and completing this study in accordance with this Clinical investigation plan.
  6. 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.
  7. Patient referred for surgical treatment of breast cancer.

Exclusion Criteria:

  1. 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.
  2. A skin disorder that prevents or contraindicates to perform a probe examination in the opinion of the investigator;
  3. Breast inflammation/infection on the day of the probe examination;
  4. Allergy to any component of the medical device that is the subject of this clinical investigation;
  5. An implant in the breast where the inPROBE study and surgery will be performed;
  6. 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;
  7. 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;
  8. Pregnancy or breastfeeding;
  9. Participation in another clinical trial within 30 days prior to signing informed consent to participate in this clinical investigation;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05415943


Locations
Layout table for location information
Poland
Uniwersyteckie Centrum Leczenia Chorób Piersi, Szpital Uniwersytecki w Krakowie Not yet recruiting
Kraków, Poland, 30-688
Contact: Diana Hodorowicz - Zaniewska, MD, PhD    +48123516602    diana.hodorowicz-zaniewska@uj.edu.pl   
Klinika Chirurgii Onkologicznej Recruiting
Lublin, Poland, 20-081
Contact: Andrzej Kurylcio, MD, PhD    +48815318126    andrzej.kurylcio@umlub.pl   
Sponsors and Collaborators
SDS Optic S.A.
Layout table for additonal information
Responsible Party: SDS Optic S.A.
ClinicalTrials.gov Identifier: NCT05415943    
Other Study ID Numbers: SDS-HER-01-2018
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases