Condition category
Cancer
Date applied
19/05/2016
Date assigned
31/05/2016
Last edited
27/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The usual method to assess the spread of breast cancer if there are no clinical or radiological signs is to perform a lymph node biopsy in the axilla (armpit). This involves detecting and resecting (removing) the first node that receives lymph from the primary (original) tumour site. This lymph node is called sentinel. The traditional technique to trace it is to use a radioactive marker as well as blue dye, which are injected in the breast and gather in the sentinel node. This is identified visually and by a probe at operation. A new promising technique is the use of magnetic particles that work in the same way; these are super paramagnetic iron oxide nanoparticles (Sienna+). This study wants to test technique as the sole method for the detection of the sentinel node.

Who can participate?
Adults (aged at least 18) about to have a sentinel node biopsy (SNB)at either the Akademiska University Hospital, Uppsala, Sweden or Västmanlands County Hospital, Västerås, Sweden.

What does the study involve?
Patients recruited at Uppsala University Hospital are allocated to the intervention group. They are given a dose of Sienna+ (along with a local anaesthetic) either during their visit to the outpatient clinic before they have their surgery or at least 20 minutes before they have their surgery. Patients recruited at the Västmanlands County Hospital undergo the usual SNB technique. All patietns are followed up to see how effective the treatment is and how feasible it is to inject the Sienna+. Patients in the intervention group are also asked (via a questionnaire) about possible skin staining after the procedure and how much of a problem do they think it is. Finally, a cost-benefit analysis is performed.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
1. Uppsala University Hospital (Sweden)
2. Västmanlands County Hospital (Sweden)

When is the study starting and how long is it expected to run for?
June 2014 to June 2016

Who is funding the study?
Uppsala University (Sweden)

Who is the main contact?
Dr Andreas Karakatsanis
andreas.karakatsanis@akademiska.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andreas Karakatsanis

ORCID ID

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

Contact details

Uppsala University Hospital (Akademiska)
ing70.
Uppsala
751 85
Sweden
0046765864826
andreas.karakatsanis@akademiska.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Ethics Comittee Uppsala University, DNR 2014/073 + 2014/073/1 + 2014/073/2.

Study information

Scientific title

The routine use of super paramagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy in patients with breast cancer. The MONOS study.

Acronym

Study hypothesis

The sole use of SPIO nanoparticles (Sienna+) is as effective as the combination of Tc99 and blue dye in the detection of sentinel nodes in patients with breast cancer.

Ethics approval

Ethics Committee Uppsala University, 29/03/2014 (ref: 2014/073) and 16/12/2015 (ref: 2014/073/2)

Study design

Prospective open label inteventional trial

Primary study design

Interventional

Secondary study design

Non-randomised study with control arm

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Breast cancer

Intervention

Patients are recruited from Akademiska University Hospital, Uppsala, Sweden and Västmanlands County Hospital, Västerås, Sweden. Patients recruited at Uppsala University Hospital will be enrolled in the SPIO (Sienna+®) arm, whereas patients at Västmanlands County Hospital in Västerås will be assigned in the control (dual technique) arm.

For the intervention group, SPIO nanoparticles (Sienna+, Sysmex Europe). The dose is 2ml of Sienna+ blended with 3ml of local anaesthetic - Xylocain®, 10mg/ml) and is injected interstitially either during the preoperative visit to the outpatient clinic or about one hour but, at least 20 minutes before the operation. If the transcutaneous signal is deemed inadequate, 1-2 ml of Patent Blue® will be administered interstitially at the areolar border 10 minutes before skin incision.

The control arm consists of patients with with breast cancer with indication for sentinel node biopsy, who will undergo SNB using the standard dual technique, consisting of interstitial injection of 40-60mBq Tc99 the morning before surgery or the day before with the addition of blue dye as above, in standard fashion.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Intraoperative detection rate per case defined as the number of successful cases per method divided by the total amount of cases performed in the respective arm (Sienna+ and Tc99).
2. Detection rate per case, specific for patients injected with Sienna+ in the preoperative outpatient setting and not perioperatively.
3. Intraoperative detection rate per node defined as the number of nodes retrieved successfully per method divided by the total amount of nodes retrieved in the respective arm (Sienna+ and Tc99).

Secondary outcome measures

1. Size and fading of staining (intervention arm only) in the postoperative period (at 3, 6, 9,12,15, 18 months) . The size of staining will be measured in maximum dimensions and the intensity of the staining will be registered as to if it is persistent or paler.
2. Problems experienced by patients due to remaining skin staining, assessed with Likert scale from 0 (not a cosmetic problem at all) to 5 (very ugly)) at 15 and 18 months postoperative.
3. Costs per method per patient
4. Primary benefit cost analysis

Overall trial start date

10/06/2014

Overall trial end date

10/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults (>18 yrs of age)
2. Mentally capable of processing information.
3. Patients scheduled for a SNB

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

At least 127 patients or procedures per arm.

Participant exclusion criteria

1. Patients with pacemaker or other implantable metallic devices in the chest
2. Patients with allergy or intolerance to iron and dextran compounds
3. Patients with hemochromatosis
4. Pregnant patients
5. Lactating patients

Recruitment start date

01/09/2014

Recruitment end date

10/06/2015

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

Box 256
Uppsala
751 05
Sweden

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Uppsala Universit

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

10/06/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes