Breast CancerNCT05377229
MarginProbe 2.0 Data Collection Protocol
An observational study of Breast Cancer, run by Dilon Medical Technologies Ltd. at 9 sites in 2 countries.
Trial summary
Previous clinical studies with the MarginProbe (MP) system demonstrated the MP System diagnostic accuracy for identification of cancerous/abnormal tissue at the margins (≤ 1mm) of the ex-vivo lumpectomy specimen. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MarginProbe2.0
- Type of treatment
- Medical device
- How many people
- 398 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 15 Dec 2021to 12 Jan 2025
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study will include measurements in cohorts of a minimum of 50 subjects up to a maximum of 1000 cases from women, aged 18 and above, undergoing breast lumpectomy/partial mastectomy surgery for previously diagnosed breast cancer.
Who may be able to join
- Women over 18 years of age
- Diagnosed with cancer, undergoing lumpectomy or partial mastectomy procedure
- Signed Informed Consent Form
Who cannot join
- Undergoing re-excision procedure
- Concurrent infectious disease
- Pregnancy
- Lactation
- Previous surgery in the same site including open biopsy procedure, previous breast reduction or mastopexy in the operated breast
- Prior radiation treatment in the operated breast
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Lehigh Valley
Bethlehem, Pennsylvania, 18017
Health and Hospitals Corporation/Kings County
Brooklyn, New York, 11203
Mercy Medical Center
Cedar Rapids, Iowa, 52403
Englewood Health
Englewood, New Jersey, 07631
Glendale Adventist Medical Center
Glendale, California, 91206
Logan Health Breast Center
Kalispell, Montana, 59901
Northwell Northern Westchester
Mount Kisco, New York, 10549
Northwell Health
Staten Island, New York, 10305
About this study
Previous clinical studies with the MarginProbe (MP) system demonstrated the MP System diagnostic accuracy for identification of cancerous/abnormal tissue at the margins (≤ 1mm) of the ex-vivo lumpectomy specimen. The current study is a prospective data collection study with the enhanced technology, the MP2.0 System and is aimed at collecting data to optimize the system algorithm/procedure and to subsequently validate the system to demonstrate non-inferiority to the MP1.x system.
In this study, MP2.0 system will be used on ex-vivo lumpectomy specimens at the Operating Room (OR). The study will collect a library of case information data using the MP2.0 system in sequential cohorts of a minimum of 50 subjects until the software and procedure are optimized. The final analysis sample size will be determined and outlined in the SAP based upon the results of the optimization stage.
- Conditions
- Breast Cancer
- Being tested
- MarginProbe2.0
- Keywords
- MarginProbe, Breast Cancer, Lumpectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarginProbe2.0Device
Also called MP2.0
The MarginProbe System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins of the ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: During the lumpectomy surgery
Collect MP2.0 data in cohorts of a minimum of 50 subjects to optimize MP2.0 algorithm and procedure.
The cohorts will continue to be collected until a final algorithm is established and the cohort(s) can be collected with the final algorithm to determine the sensitivity and specificity to demonstrate non-inferiority to the MP1.x system.
Measured: During the lumpectomy surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start15 Dec 2021
- Primary completion23 Aug 2024
- Study completion12 Jan 2025
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dilon Medical Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377229
- Sponsor's protocol ID
- CP-13-001
- Status last verified
- Aug 2025
- First submitted
- 9 May 2022
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MarginProbe 2.0 Data Collection Protocol
- ClinicalTrials.gov ID
- NCT05377229
- Acronym / sponsor ID
- CP-13-001
- Conditions
- Breast Cancer
- Keywords
- MarginProbe, Breast Cancer, Lumpectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Dilon Medical Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 12 Jan 2025 (actual)
- First posted
- 17 May 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.
Previous clinical studies with the MarginProbe (MP) system demonstrated the MP System diagnostic accuracy for identification of cancerous/abnormal tissue at the margins (≤ 1mm) of the ex-vivo lumpectomy specimen. The current study is a prospective data collection study with the enhanced technology, the MP2.0 System and is aimed at collecting data to optimize the system algorithm/procedure and to subsequently validate the system to demonstrate non-inferiority to the MP1.x system.
In this study, MP2.0 system will be used on ex-vivo lumpectomy specimens at the Operating Room (OR). The study will collect a library of case information data using the MP2.0 system in sequential cohorts of a minimum of 50 subjects until the software and procedure are optimized. The final analysis sample size will be determined and outlined in the SAP based upon the results of the optimization stage.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include measurements in cohorts of a minimum of 50 subjects up to a maximum of 1000 cases from women, aged 18 and above, undergoing breast lumpectomy/partial mastectomy surgery for previously diagnosed breast cancer.
Key inclusion criteria (3 listed)
- Women over 18 years of age
- Diagnosed with cancer, undergoing lumpectomy or partial mastectomy procedure
- Signed Informed Consent Form
Key exclusion criteria (7 listed)
- Undergoing re-excision procedure
- Concurrent infectious disease
- Pregnancy
- Lactation
- Previous surgery in the same site including open biopsy procedure, previous breast reduction or mastopexy in the operated breast
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 |
|---|---|---|
| MarginProbe2.0Also: MP2.0The MarginProbe System is an adjunctive diagnostic tool for identification of cancerous tissue at the margins of the ex-vivo lumpectomy specimen following primary excision and is indicated for intraoperative use, in conjunction with standard methods (such as intraoperative imaging and palpation) in patients undergoing breast lumpectomy surgery for previously diagnosed breast cancer. | Device | – |
Primary outcome
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: During the lumpectomy surgery
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Collect MP2.0 data in cohorts of a minimum of 50 subjects to optimize MP2.0 algorithm and procedure.
Time frame: During the lumpectomy surgery
The cohorts will continue to be collected until a final algorithm is established and the cohort(s) can be collected with the final algorithm to determine the sensitivity and specificity to demonstrate non-inferiority to the MP1.x system.
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 28 Aug 2025.
- Individual participant dataSharing planned: No
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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.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Dilon Medical Technologies Ltd. at 9 sites in 2 countries.
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 3 inclusion and 7 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 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Israel. 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?
Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: During the lumpectomy surgery). The study lists 2 primary outcomes in all. 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 28 Aug 2025.