Neoplasms

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Breast Neoplasms

Breast Diseases

Skin Diseases

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.

MarginProbe2.0

Maya Livnat

Research Office

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.

MarginProbe 2.0 Data Collection Protocol

Adverse Events (AEs) and Serious Adverse Events (SAEs)

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.

Dilon Medical Technologies Ltd.

Randomized for MarginProbe device to be used during surgical procedure

Randomized for surgical procedure to happen as per standard care

Surgery to take place as per standard care. When the surgery is nearly concluded, patient to be randomised. If randomised to device arm, the MarginProbe device will be used on the outer edge of the tumour and shavings. If the MarginProbe device indicates that cancer is detected, a further shaving is to be taken. Surgery then to be concluded as per standard care.

MarginProbe

The new device we are looking at is called the MarginProbe. It is a disposable probe which measures the margins of tissue removed to check they are clear of cancer cells, during breast conservation surgery. After specimen radiology, allows the Surgeon to remove further tissue if necessary, during the same operation if any involved margins are identified. This minimises the need for further repeat operations.

Previous studies carried out elsewhere in the world (USA and Israel) have identified that the probe reduces re-excision rate but there has never been a study in the UK.

The trial involves randomly allocating patients once they are in theatre, to either the MarginProbe procedure after breast conserving surgery and radiology has been completed, or not.

Almost 60% of all patients diagnosed with breast cancer (48000 annually in the UK) undergo breast conserving surgery (BCS. Surgical removal of the cancer aims to reduce the risk of local recurrence and patient mortality. In order to minimise the amount of tissue removed, excision up to the cancer-free area (margins) is undertaken. Further surgery, following initial breast cancer surgery, is required in 25% - 30% of patients because of disease found at the edges of the tissue removed.

Reducing the need for further operations benefits patients (by reducing the number of operations required, improving cosmetic outcome and minimising anxiety) and the NHS (by realising economic benefits).

MarginProbe, a disposable probe which measures the margins of tissue removed during breast cancer surgery, allows the surgeon to remove further tissue during the same surgical procedure to clear any involved margins, minimising subsequent re-operations. Four hundred and sixty patients in 6 specialist Breast Units will be randomly allocated after BCS (and specimen radiology), by telephone randomisation, to either:

* MarginProbe assessment of the surgical specimen with re-excision of margins if required;
* Standard BCS (clinical and radiological clear margins) whereby the wound will be closed and the surgery completed (standard UK practice).

Does Intra-operative MarginProbe Use Reduce Re-excision Rates?

Reducing Re-excisions After Breast Conserving Surgery: A Randomized Controlled Trial Comparing the MarginProbe Device in Addition to Standard Operating Procedure Versus Standard Operating Procedure Alone in Preventing Re-excision

Peer Reviewed Scientific Journals Conference Presentation Publication on Website Access to raw data by Independent Steering Committee

To determine if the use of the MarginProbe device, after surgical tumour excision and tissue specimen radiography of a breast cancer reduces rates of further surgical re-excision operations (re-excision or mastectomy), when compared to control/standard practice(whereby the wound is closed after radiography showing clear margins).

To determine the effect of checking for disease free tissue during the patients breast cancer surgery using the MarginProbe device (when compared to standard practice) on quality of life and Patient Related Outcome Measures.

To determine Quality of life and health related facility measures (EQ5D) between patient groups.

To compare the number of patients in both groups presenting with disease free margins greater than 1mm (circumferentially) after breast cancer surgery, using a laboratory histopathological assessment.

To compare the total number of re-excision procedures required in both groups (including mastectomy)following breast cancer surgery because of small (less than 1mm) disease free margins.

Comparing digital photography assessment \[2 views; front and side\] to assess cosmetic outcomes in both study arms.

Manchester University NHS Foundation Trust

Single arm study - MarginProbe in addition to standard procedure

Intraoperative MarginProbe use as adjunct to standard practice MarginProbe will be used on the lumpectomy specimen within 20 minutes of excision, prior to specimen Xray or gross pathology evaluation. This may take up to 5 minutes. MarginProbe will indicate a positive or negative reading for each of the 6 circumferential margins, and the results will be recorded. Any margins determined by to \< 5-10 mm by specimen Xray or gross pathology examination will be re-excised. In addition, any additional margins not already identified as \< 5-10 mm, but identified as positive by MarginProbe will be re-excised where feasible.

Jeannie Shen, MD

The combination of breast conserving surgery (lumpectomy) with radiation therapy has been shown to result in equivalent overall survival rates compared to mastectomy for the local treatment of breast cancer. As a result, the majority of patients diagnosed with breast cancer in the United States undergo lumpectomy as their primary surgical therapy. Multiple studies have demonstrated the association between positive lumpectomy margins and an increased risk of ipsilateral breast tumor recurrence, even with postoperative radiation. Studies report 20-40% of lumpectomy procedures result in one or more involved (positive) surgical margins, leading to the need for further surgery, emotional distress, poorer cosmesis, delay to adjuvant treatments, and increased cost. Current available intraoperative margin assessment techniques include specimen Xray, gross pathology, frozen section, and touch prep cytology. To reduce the incidence of positive margins, the MarginProbe (Dune Medical Devices, Caesarea, Israel) was developed to provide real-time, intraoperative assessment of the presence of tumor at the lumpectomy margin. In the current study, the investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to standard practice for intraoperative identification of tumor at lumpectomy margins, and its ability to reduce positive margins and decrease the need for additional surgical procedures.

In the current study, the investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to standard practice for intraoperative identification of tumor at lumpectomy margins, and its ability to reduce positive margins and decrease the need for additional surgical procedures.

Aims of the study:

Primary objectives

1. Determine positive margin rate following lumpectomy

Secondary objectives

1. Determine accuracy of intraoperative margin assessment with use of MarginProbe plus standard of care (gross pathologic examination and/or intraoperative specimen Xray) versus standard of care (gross pathologic examination and/or intraoperative specimen Xray) alone.
2. Determine impact of MarginProbe on total tissue volume removed
3. Determine the impact of MarginProbe on the need for additional surgical procedures.

Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe

A Phase II Study of the Outcomes of Intraoperative Margin Assessment With Adjunctive Use of MarginProbe in Addition to Standard

Huntington Memorial Hospital

Medical director, Breast Surgery

Rare Diseases

Dilated Cardiomyopathy 1A

Standard of Care arm - standard of care lumpectomy procedure

Use of the device in addition to the standard of care lumpectomy procedure.

Device use to assess margin status of the excised specimen surface.

Lumpectomy

Tanir M. Allweis, MD

Moshe Carmon, MD

Tami Karni, MD

Alison Estabrook, MD

Freya Schnabel, MD

Rache M. Simmons, MD

Sheldon M. Feldman, MD

Mark A. Gittelman, MD

Neil Friedman, MD

Kristen L. Fernandez, MD

Shawna C. Willey, MD

Lorraine Tafra, MD

Karen Lane, MD

Jay Harness, MD

Alice Police, MD

Dennis R. Holmes, MD

Scott Karlan, MD

Stephanie Akbari, MD

Thomas Frazier, MD

Lisa E. Guerra, MD

Susan K. Boolbol, MD

The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.

The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.

MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery

Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively

Dune Medical Devices

Standard of Care arm - standard of care lumpectomy procedure

Lumpectomy: Standard of care lumpectomy procedure

Standard of Care (SOC)

Use of the device in addition to the standard of care lumpectomy procedure.

MarginProbe: Device use to assess margin status of the excised specimen surface.

Lumpectomy: Standard of care lumpectomy procedure

Device + (Standard of Care) SOC

Roll-in

Total

Age, Continuous

Sex: Female, Male

Clinical Research Manager

The Analysis Set for evaluating intraoperative assessment consisted of patients with at least one histologically positive margin on main lumpectomy specimen ("PSS" - Positive specimen subjects)

The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MarginProbe 2.0 Data Collection Protocol	NCT05377229	Breast Cancer	MarginProbe2.0	18 Years -	Dilon Technologies Inc.
MarginProbe 2.0 Data Collection Protocol	NCT05377229	Breast Cancer	MarginProbe2.0	18 Years -	Dilon Technologies Inc.
Does Intra-operative MarginProbe Use Reduce Re-excision Rates?	NCT02774785	Breast Cancer	MarginProbe	18 Years - 90 Years	Manchester University NHS Foundation Trust
Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe	NCT02456649	Breast Cancer	MarginProbe	-	Huntington Memorial Hospital
Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe	NCT02456649	Breast Cancer	MarginProbe	-	Huntington Memorial Hospital
MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery	NCT00749931	Breast Cancer	MarginProbe Lumpectomy	18 Years - 90 Years	Dune Medical Devices

Spots Global Cancer Trial Database for marginprobe

Every month we try and update this database with for marginprobe cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for marginprobe

Every month we try and update this database with for marginprobe cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for marginprobe cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.