Does Intra-operative MarginProbe Use Reduce Re-excision Rates? (NCT02774785) | Clinical Trial Compass
CompletedNot Applicable
Does Intra-operative MarginProbe Use Reduce Re-excision Rates?
United Kingdom127 participantsStarted 2016-03-22
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.