Breast CancerNCT05415943
Safety and Efficacy Assessment of Diagnostic Microprobe (inPROBE) in Women at High Risk of Breast Cancer (Part I Study)
A study testing Diagnostic microprobe (inPROBE) medical device in people with Breast Cancer, run by SDS Optic S.A. at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Diagnostic microprobe (inPROBE) medical device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesPoland
- Study dates
- 24 Aug 2022to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Uniwersyteckie Centrum Leczenia Chorób Piersi, Szpital Uniwersytecki w Krakowie
Krakow, 30-688
Klinika Chirurgii Onkologicznej
Lublin, 20-081
About this study
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
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
- Being tested
- Diagnostic microprobe (inPROBE) medical device
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic microprobe (inPROBE) medical deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Diagnostic microprobe (inPROBE) medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 1
Secondary outcomes (2)
The occurrence of defects, failures, and fractures of the inPROBE probe during the diagnostic procedure leading to AE/ SAE.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start24 Aug 2022
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- SDS Optic S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415943
- Sponsor's protocol ID
- SDS-HER-01-2018
- Status last verified
- Jul 2023
- First submitted
- 7 Jun 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05415943
- Acronym / sponsor ID
- SDS-HER-01-2018
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- SDS Optic S.A.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women at high risk of breast cancer | Experimental | Device: Diagnostic microprobe (inPROBE) medical deviceWomen with a confirmed diagnosis of breast cancer by thick-needle biopsy and known HER2 receptor expression status, referred for surgical treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic microprobe (inPROBE) medical deviceIntroduction of the inPROBE microprobe (two simultaneous punctures) into the breast as a procedure prior to surgical resection of tumors with known HER2 receptor status. | Device | Women at high risk of breast cancer |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic microprobe (inPROBE) medical device in people with Breast Cancer, run by SDS Optic S.A. at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.