Breast CancerMarginProbeNCT02774785
Does Intra-operative MarginProbe Use Reduce Re-excision Rates?
A study testing MarginProbe in people with Breast Cancer, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MarginProbe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Mar 2016to 16 Feb 2021
- Phase
- Interventional
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, England, M23 9LT
About this study
Official title: 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
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.
Read the 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
- Being tested
- MarginProbe
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarginProbeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Device Arm | Experimental | Randomized for MarginProbe device to be used during surgical procedure Receives: Device: MarginProbe |
| Control Arm | No intervention | Randomized for surgical procedure to happen as per standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 9 months post surgery
Secondary outcomes (5)
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.
Measured: 9 months post surgery
EQ5D
To determine Quality of life and health related facility measures (EQ5D) between patient groups.
Measured: 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.
Measured: 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.
Measured: 9 months post surgery
Cosmetic Outcome
Comparing digital photography assessment [2 views; front and side] to assess cosmetic outcomes in both study arms.
Measured: 9 months post 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 2016 (estimated)
- Study start22 Mar 2016
- Primary completion17 Dec 2019
- Study completion16 Feb 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774785
- Sponsor's protocol ID
- 161393
- Other IDs
- PB-PG-0712-28108, 15-NW-0306
- Acronym
- MarginProbe
- Status last verified
- Nov 2021
- First submitted
- 22 Mar 2016
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Peer Reviewed Scientific Journals Conference Presentation Publication on Website Access to raw data by Independent Steering Committee
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02774785
- Acronym / sponsor ID
- MarginProbe / 161393
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 22 Mar 2016 (actual)
- Primary completion
- 17 Dec 2019 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 17 May 2016 (estimated)
- 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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device Arm | Experimental | Device: MarginProbeRandomized for MarginProbe device to be used during surgical procedure |
| Control Arm | No intervention | –Randomized for surgical procedure to happen as per standard care |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| MarginProbeSurgery 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 | Device Arm |
Primary outcome
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.
Time frame: 9 months post 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).
5 secondary outcomes
Quality of Life
Time frame: 9 months post surgery
EQ5D
Time frame: 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.
Time frame: 9 months post surgery
Total number of re-excisions
Time frame: 9 months post surgery
Cosmetic Outcome
Time frame: 9 months post surgery
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 2 Nov 2021.
- Individual participant dataSharing planned: Yes. Peer Reviewed Scientific Journals Conference Presentation Publication on Website Access to raw data by Independent Steering Committee
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MarginProbe in people with Breast Cancer, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 4 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 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
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. (time frame: 9 months post surgery). 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 2 Nov 2021; AzTrials last refreshed its copy on 27 Oct 2026.