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

NCT ID: NCT02774785

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-22
• Study Completion Date: 2021-02-16

Brief Summary

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

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Device Arm

Randomized for MarginProbe device to be used during surgical procedure

Group Type: EXPERIMENTAL

MarginProbe

Intervention Type: DEVICE

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.

Control Arm

Randomized for surgical procedure to happen as per standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MarginProbe

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Manchester University NHS Foundation Trust

Manchester, England, United Kingdom

Countries

United Kingdom

Other Identifiers

PB-PG-0712-28108

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

15-NW-0306

Identifier Type: OTHER

Identifier Source: secondary_id

161393

Identifier Type: -

Identifier Source: org_study_id