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

NCT02774785 | Completed DMC

• 3 other identifiers: 161393PB-PG-0712-2810815-NW-0306
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of Life

  9 months post surgery

• EQ5D

  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.

  9 months post surgery

• Total number of re-excisions

  9 months post surgery

• Cosmetic Outcome

  9 months post surgery

Study Arms (2)

Device Arm

EXPERIMENTAL

Randomized for MarginProbe device to be used during surgical procedure

Device: MarginProbe

Control Arm

NO INTERVENTION

Randomized for surgical procedure to happen as per standard care

Interventions

MarginProbe 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.

Device Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, England, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: May 17, 2016
• Study Start: March 22, 2016
• Primary Completion: December 17, 2019
• Study Completion: February 16, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)