Mastectomy - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

University Hospital of South Manchester

Recruitment countries:

United Kingdom

Health condition studied:

Breast cancer
Cancer
Breast cancer

URL:

Link to the clinical trial website

About the trial

Interventions:

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.

Key inclusion and exclusion criteria:

• 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
• 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.

• Age minimum: 
• Age maximum: 
• Gender:  Both

Primary outcomes:

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 outcomes:

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

Target sample size:

460

Study type:

Interventional

Study design:

Randomised; Interventional; Design type: Prevention, Device, Surgery (Treatment)

Contacts:

• Name:  
• Address: 
• Phone: 
• Email: 
• Affiliation: 

• Name: Donna Watterson
• Address:  University Hospital of South Manchester NHS Foundation Trust The Nightingale Centre and Genesis Prevention Centre Wythenshawe Hospital Southmoor Road Wythenshawe
• Phone:  +44 161 291 4045
• Email:  donna.watterson@uhsm.nhs.uk
• Affiliation: 

Technical details

Scientific title:

Does intra­operative use of the MarginProbe device reduce the need for further re­-excision procedures after conservation surgery for breast cancer?

Sources of monetary support:

National Institute for Health Research

Secondary sponsors:

Main ID:

ISRCTN10169595

Secondary ID:

19495

Register:

ISRCTN

Date of registration:

27/03/2017

Date of first enrollment:

22/03/2016

Last refreshed:

8 May 2017