Contact information
Type
Public
Primary contact
Miss Donna Watterson
ORCID ID
Contact details
University Hospital of South Manchester NHS Foundation Trust
The Nightingale Centre and Genesis Prevention Centre
Wythenshawe Hospital
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
+44 161 291 4045
donna.watterson@uhsm.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT02774785
Protocol/serial number
19495
Study information
Scientific title
Does intraoperative use of the MarginProbe device reduce the need for further re-excision procedures after conservation surgery for breast cancer?
Acronym
Study hypothesis
Study aims:
1. To determine if intraoperative margin assessment after excision of a cancer reduces second operations (re-excision or mastectomy), compared to standard surgical practice by 9 months after primary surgery
2. 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)
Ethics approval
North West/Greater Manchester West REC, 05/06/2015, ref: 15/NW/0306
Study design
Randomised; Interventional; Design type: Prevention, Device, Surgery
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer
Intervention
All surgeons will perform standard wide local excision (BCS) using localisation of the lesion for impalpable lesions where required. Randomization will take place immediately after the main ex-vivo lumpectomy specimen has been excised, oriented, border marked, inspected, palpated and additional cavity shavings (per visual inspection, palpation and radiology) performed. Patients will be randomised in theatre, by call to the MAHSC CTU, to either standard procedure alone or standard procedure with the use of the MarginProbe device:
Device Arm: Measurements shall be taken with the MarginProbe on the outer final surface of each margin. Once the device has been applied to outer final surface of all margins, all margins with one or more positive readings on it should be shaved from the cavity. The procedure will then be concluded in the routine practice.
Control Arm: The procedure will be concluded in the routine practice.
MarginProbe use starts and ends during the primary lumpectomy procedure. Thus, patient management differs between the two study arms only during the procedure. Following the procedure, pathological assessment and any other patient management aspects are identical for both study arms. The follow-up period for both study arms is 9 months. Follow up visits (month 1, 6 and 9): FACT B +4, HADS and EQ5D Questionnaires and Patient Diary Cards Administered. Photographs for cosmesis completed at baseline and 9 months.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Reduction rates in re-excision procedures are determined by review of pathology reports for all participants to record subsequent surgeries at 9 months post initial surgery
2. Total number of re-excision procedures is determined by review of patient notes, clinical data and pathology reports at 9 months post initial surgery
3. Excision margins determined by review of pathology reports at 9 months post initial surgery
Secondary outcome measures
1. Quality of life measured by using validated self-completion disease specific and generic instruments, FACT-B, HADS, health-related utility (EQ5D) and the body image scale of SABIS administered at baseline (pre-surgery) and postal follow-up at 1, 3 and 9 months post-surgery
2. Cosmetic outcome assessment will be performed by two objective evaluators blinded to arm assignment based on pictures taken under standardized photographic conditions. The scoring will be performed using the validated 4-point Harvard scale. Pictures will be taken at baseline and 9 months post-surgery.
3. Impact of margin assessment on patients and carers will be measured by questionnaires assessing experiences and satisfaction and semi structured interviews exploring concerns, expectations, preferences, satisfaction and awareness of procedural differences. This will be a qualitative sub study of the main trial and timescales are dependent on when this is set up.
4. Clinical and cost effectiveness measured by review of hospital in-patient records and patient diary cards at 1, 3 and 9 months
Overall trial start date
24/03/2014
Overall trial end date
12/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged 18-90 years with DCIS or Invasive Breast cancer containing DCIS diagnosed histopathologically
2. Histologically diagnosed DCIS or invasive lobular cancer in core biopsy (B5a or B5b). Invasive lobular carcinoma does not require concomitant DCIS.
3. Tumour size 1.5cm - 4cm and undergoing BCS
4. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 460; UK Sample Size: 460
Total final enrolment
467
Participant exclusion criteria
1. Unsuitable for BCS on basis of tumour size (>4cm) or stage.
2. Radiotherapy contraindicated.
3. No histopathological evidence of DCIS or invasive lobular cancer.
4. Small invasive cancers (<1.5cm)
5. Multicentric Disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen
6. Bilateral disease (diagnosed cancer in both breasts)
7. Neoadjuvant systemic therapy
8. Previous radiation in the operated breast
9. Implants in the operated breast
10. Pregnancy
11. Lactation
12. Cryo-assisted localisation
13. Patients who are undergoing full cavity excision following removal of the main lumpectomy specimen during initial lumpectomy procedure.
Recruitment start date
22/03/2016
Recruitment end date
31/10/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wythenshawe Hospital
University Hospital of South Manchester NHS Foundation Trust
The Nightingale Centre and Genesis Prevention Centre
Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom
Trial participating centre
St James's University Hospital
Leeds Teaching Hospitals NHS Trust
Bexley Wing,
Beckett Street
Leeds
LS9 7TF
United Kingdom
Trial participating centre
Royal Derby Hospital
Derby Teaching Hospitals NHS Foundation Trust
Lymphoedema and Palliative Medicine
M&G Level 3
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Trial participating centre
Addenbrookes Hospital
Cambridge University Hospitals NHS Foundation Trust
NIHR CRN Eastern
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Trial participating centre
Western General Hospital
NHS Lothian
Edinburgh Breast Unit
Edinburgh
EH4 2XU
United Kingdom
Trial participating centre
Macclesfield District General Hospital
Cancer Resource Centre
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Trial participating centre
The Royal Bournemouth and Christchurch Hospitals
Castle Ln E
Bournemouth
BH7 7DW
United Kingdom
Sponsor information
Organisation
University Hospital of South Manchester
Sponsor details
Southmoor Road
Manchester
M23 9LT
United Kingdom
+44 161 291 4045
sian.hannison@manchester.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal with intention to publish the findings from the trial approximately 1 year after trial closure.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from nigel.bundred@manchester.ac.uk
Intention to publish date
30/06/2021
Participant level data
Available on request
Basic results (scientific)
Publication list