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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: MarginProbe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria; Women aged 18-90 years with DCIS or Invasive Breast cancer containing DCIS diagnosed histopathologically. Histologically diagnosed DCIS or invasive lobular cancer in core biopsy (B5a or B5b). Tumour size 1.5cm - 4cm and undergoing breast cancer surgery. Written informed consent. Exclusion Criteria; Unsuitable for BCS on basis of tumour size (<1.5cm or >4cm) or stage. Radiotherapy contraindicated. No histopathological evidence of DCIS or invasive lobular cancer. Neoadjuvant chemotherapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Arm<br>Randomized for MarginProbe device to be used during surgical procedure | Device: MarginProbe<br>* 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.<br>|
| No Intervention: Control Arm<br>Randomized for surgical procedure to happen as per standard care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if intraoperative margin assessment after excision of a cancer reduces second operations (reexcision or mastectomy), compared to standard surgical practice by 9 months after primary surgery. | 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). | 9 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | 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. | 9 months post surgery | 
| EQ5D | To determine Quality of life and health related facility measures (EQ5D) between patient groups. | 9 months post surgery | 
| 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 number of patients in both groups presenting with disease free margins greater than 1mm (circumferentially) after breast cancer surgery, using a laboratory histopathological assessment. | 9 months post surgery | 
| Total number of re-excisions | 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. | 9 months post surgery | 
| Cosmetic Outcome | Comparing digital photography assessment [2 views; front and side] to assess cosmetic outcomes in both study arms. | 9 months post surgery |