Condition category
Cancer
Date applied
27/03/2018
Date assigned
01/05/2018
Last edited
17/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims: The study aims to compare a new technique of tumour marking in patients with breast cancer.

Who can participate?
Adult women with non-palpable breast cancer (cancer that cannot be felt using the fingers) suitable for
breast-conserving surgery.

What does the study involve?
Study participants will be randomised to the marking of the breast tumour with either a guide wire (a thin wire placed into the tumor using a mammogram or ultrasound) or a magnetic clip that will serve as a guide for tumour removal with guidance during the operation from a hand-held magnetism detector.

What are the possible benefits and risks of participating?
Patients participating in the study will undergo a closer follow-up in the postoperative period. No financial reimbursement will be provided. The risks are the same as for a simple breast tissue biopsy and include pain, swelling and bruising.

Where is the study run from?
The study is run from the Breast Unit of Uppsala University Hospital, which is the lead centre. The trial will be undertaken in Uppsala University Hospital and in Västmanlands County Hospital.

When is the study starting and how long is it expected to run for? The study is expected to start recruiting by May 1st, 2018. Patient recruited is expected to be completed by October 2018.

Who is funding the study?
The study is funded by Uppsala University. The magnetic markers (Magseed) and the tracer for the sentinel node biopsy (SiennaXP) will be provided by EndoMagnetics (Cambridge, UK).

Who is the main contact
Main contact for the study is Andreas Karakatsanis, MD, PhD, FEBS, Consultant Oncoplastic Surgeon, Uppsala University Hospital.





Trial website

Contact information

Type

Scientific

Primary contact

Dr Andreas Karakatsanis

ORCID ID

http://orcid.org/0000-0003-3622-3575

Contact details

Department for Surgical Sciences
Entrance 70
Uppsala University Hospital
Uppsala
751 85
Sweden
0046765864826
andreas.karakatsanis@surgsci.uu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MagTotal

Study information

Scientific title

Tumour localization and sentinel lymph node identification using a magnetic localisation marker (Magseed) and super paramagnetic iron oxide nanoparticles (SiennaXP): The randomised MagTotal trial

Acronym

MagTotal

Study hypothesis

The MagSeed tracer is non-inferior to the guidewire in successful resection of the primary tumour.

Ethics approval

Uppsala Regional Ethics Commitee, 10/01/2018, DNR 2017/508

Study design

Open-label randomised controlled trial

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

Patients partaking in the study will be allocated to marking of the tumour either with Magseed or a guidewire. Allocation will be performed with block randomisation using a block size of 10 and an allocation ratio of 1:1 using a random number generator software . The SPIO Sienna XP© will be injected in the preoperative period, peritumorally by the breast radiologist guided by ultrasound or mammography in non-palpable lesions. At the same time, the breast radiologist will insert the Magseed close to the tumour in patients allocated in the Magseed arm. In patients randomised to tumour localization by guide wire, the guide wire will be inserted on the same day as the surgery.

During breast-conserving surgery (BCS) the transcutaneous signal by SentiMag in the breast and axilla, as well as the presence and size of skin staining will be registered. After the excision of the primary tumour, a specimen count as well as a background count will be performed.
In the post-operative visit to the outpatient clinic, staining and magnetic signal in the breast will be registered. At the postoperative multidisciplinary team meeting the need of a reoperation due to non-radical resection will be registered. The number of sentinel nodes (SNs) and non-SNs and the occurrence of lymph node metastases will be registered.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Radical excision, defined as free surgical margins of the specimen of the primary tumour according to preoperative diagnosis.

Secondary outcome measures

1. Width of margins per study arm in mm from the tumour to the resection margin both on specimen radiology and on final pathology.
2. Operative time from the beginning of the breast operation until the excision of the specimen in minutes.
3. Intraoperative and postoperative complications on 30 days, described by the Clavien Dindo classification and the Comprehensive Complication Index (CCI) (www.assessurgery.com).
4. Cost/benefit analysis based on the expenses of inpatient and outpatient care regarding the operation and 30 days of the postoperative period.

Overall trial start date

24/10/2017

Overall trial end date

30/10/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Ductal carcinoma in situ (DCIS) or invasive breast cancer requiring localisation planned for primary surgery including sentinel node biopsy

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Intolerance or hypersensitivity to iron or dextran compounds or Sienna XP
2. Iron overload disease
3. Pacemaker or other implantable device in the chest-wall, or prosthesis in the shoulder
4. Deprived of liberty or under guardianship
5. Pregnant or lactating
6. Inability to provide informed consent

Recruitment start date

01/04/2018

Recruitment end date

30/09/2018

Locations

Countries of recruitment

Sweden

Trial participating centre

Uppsala University Hospital
Uppsala
751 85
Sweden

Trial participating centre

Västmanlands County Hospital
Västerås
721 89
Sweden

Sponsor information

Organisation

Uppsala University

Sponsor details

Uppsala University
Uppsala
751 05
Sweden

Sponsor type

University/education

Website

uu.se

Funders

Funder type

Not defined

Funder name

Endomagnetics, Cambridge, UK

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing statement
The datasets generated during and analysed during the current study will be available upon request from Andreas Karakatsanis (andreas.karakatsanis@surgsci.uu.se) and Fredrik Wärnberg (fredrik.warnberg@surgsci.uu.se) after all results have been originally published. Anonymised patient level data after appropriate patient consent will be made available for scientific and academic purposes, i.e. for the conduct of pooled analyses or patient level meta-analyses. Study data will be kept for 20 years.

Intention to publish date

01/11/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes