Multidetector computed tomography to improve surgical outcomes in breast cancer

ISRCTN	ISRCTN03659464
DOI	https://doi.org/10.1186/ISRCTN03659464
Secondary identifying numbers	Version 2

Submission date: 13/10/2010
Registration date: 09/11/2010
Last edited: 27/03/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://cancerhelp.cancerresearchuk.org/trials/trial-looking-at-ct-scans-before-surgery-breast-cancer

Contact information

Dr Julie Cox
Scientific

Department of Radiology
University Hospital North Durham
Durham
DH1 5TW
United Kingdom

Phone	+44 (0)191 333 2491
Email	julie.cox@cddft.nhs.uk

Study information

Study design	Randomised controlled trial using a PROBE design (prospective randomised open blinded end-point)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Multidetector Computed Tomography to Improve Surgical Outcomes in Breast Cancer (MISOBC): a randomised controlled trial
Study acronym	MISO-BC
Study objectives	This study is a prospective randomised open blinded end-point (PROBE) study comparing routine and CT-enhanced diagnostic and surgical care in patients presenting with primary breast cancer in whom axillary surgery is planned. Currently SLNB has a 25% re-operation rate (ALNB) if malignant lymph nodes are found in the axilla at the initial operation in our hospital. The study is designed to detect a reduction in re-operation rate to 10% . This is the primary scientific aim of the study.
Ethics approval(s)	The Newcastle and North Tyneside Research Ethics Committee (REC) 2, 14/09/2010, ref: 10/H0907/42
Health condition(s) or problem(s) studied	Breast cancer
Intervention	When patients present with breast symptoms they are usually referred by their general practitioners for assessment in a one-stop breast clinic. At the clinic, they will undergo clinical assessment by a breast surgeon, and ultrasound and mammography (depending on the age of the patient), as well as needle sampling of the breast lump (usually either Fine Needle Aspiration Cytology or Core Biopsy). When there is a positive diagnosis of a breast cancer made, the patients are informed at a second outpatient appointment by a consultant breast surgeon. After they have received their diagnosis, the surgeon will discuss the MISO BC trial with them and provide them with a patient information leaflet. The surgeon will ask the patient whether they would be willing to be contacted in the near future about possible participation in the trial. Within two to four days, the patients who have agreed contacted will be phoned by the Site Trial Coordinator (STC), who will discuss the trial with them. If the patient wishes to enter the trial, the STC will take verbal consent, which will be recorded in writing in the patient notes. The STC will then randomise the patient and convey the result to them. If they are randomised to the group having the CT scan, an appointment within a week will be provided for the patient to attend to have the scan. Written consent for the trial will be obtained by the Trial Nurse at the time of the CT scan. For those patients randomised to the group not having a CT scan, the Site Trial Coordinator will confirm with the patient when their next hospital attendance will be and arrange to meet them. Written consent will be obtained for entry into the trial by the Site Trial coordinator at the next hospital attendance which will usually be for preassessment for surgery. Patients from both groups will have undergone a routine axillary ultrasound examination with or without core biopsy at the time of their initial assessment in the one stop breast clinic. The non CT axilla group will have their axillary surgery as planned. Patients who are randomised to have a CT scan will have their scan performed through the ipsilateral axilla (same as the side of the cancer) using the 64 slice Aquilion scanner (Toshiba Medical) at the University Hospital of North Durham. CT and other diagnostic test procedures will be conducted and recorded in a blinded fashion. The findings, together with the results of axillary ultrasound, will be discussed at the Breast MDT and the appropriate axillary surgery (either SLNB or ALND) decided upon. Test results will then be correlated with histopathological results obtained from the axillary surgery (the test reference standard) in order to determine the sensitivity and specificity of the CT examination. Histopathological determination will be conducted by a pathologist blinded to test findings. Thus the test performance of ultrasound (+/- core biopsy) and CT alone and in combination will be estimated. After the axillary surgery, the status of the nodal disease together with any further required surgery or management of complications will be recorded within trial. Approximately two weeks after the final episode of surgery, the patients will be telephoned by the Site Trial Coordinator and interviewed about their experiences. Additional data required for the trial will be extracted from the medical notes for each patient that consents to the trial. The trial period will extend from the time of verbal consent to two weeks after the last surgical procedure. The subjects will be contacted by the Site Trial Coordinator who will then go through the Patient Experience Survey with them. This will represent the end of the patients' participation in the trial. As a guide for most patients, the total duration of the trial period will be between 4-8 weeks.
Intervention type	Other
Primary outcome measure	Change in the rate of re-operation on the axilla when comparing CT-informed and routine care.
Secondary outcome measures	1. Patient satisfaction (as evidenced by patient satisfaction questionnaires) at 2 weeks post surgery 2. The sensitivity, specificity, and positive and negative predictive values of ultrasound of the axilla, ultrasound with needle sampling and mulidetector CT 3. Economic analysis 4. Rates of common post surgical complications in both groups including wound infections, serous axillary collections, and lymphoedema
Overall study start date	01/11/2010
Completion date	01/05/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	300
Key inclusion criteria	1. Male or female, aged 18 years or over 2. Have undergone ultrasound scanning and/ or mammography for their current breast cancer diagnosis 3. Have pathologically documented primary invasive breast carcinoma 4. Be suitable for axillary surgery 5. Be able to provide written informed consent
Key exclusion criteria	1. Are medically unstable as judged by the Chief Investigator or Trial Nurse 2. Are known to have had an allergic reaction associated with previous administration of iodinated contrast agent or have a severe allergic diathesis 3. Require renal dialysis 4. Have had previous surgery or radiotherapy for cancer to the ipsilateral (same side) axilla 5. Pregnant patients
Date of first enrolment	01/11/2010
Date of final enrolment	01/05/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University Hospital North Durham

Durham
DH1 5TW
United Kingdom

Sponsor information

Darlington Memorial Hospital (UK)
Hospital/treatment centre

c/o Mrs Lynne Williams
Reseach and Development Manager
Research and Development Office
Hollyhurst Rd
Darlington
DL3
United Kingdom

Phone	+44 (0)191 333 2333
Email	lynne.williams@cddft.nhs.uk
"ROR"	https://ror.org/00vwfb160

Funders

Funder type

Government

National Institute of Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme (ref: PB-PG-0609-18085)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2017		Yes	No

Editorial Notes

27/03/2018: Publication reference added.
23/02/2016: No publications found, verifying study status with principal investigator