NCT02612870

Brief Summary

Patients with breast cancer normally undergo a labelling with radioactive tracer typically 1 day before surgery, which enables the surgeon to localize the sentinel lymph node during surgery. This pilot study uses the magnetic Sentimag technique to mark the lymph nodes either 1 or 4-6 days before surgery to investigate the concordance with the standard technique.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

November 18, 2015

Last Update Submit

November 23, 2015

Conditions

Breast Neoplasms

Keywords

Breast CancerSentinel NodeSentinel Node BiopsyBreast Surgery

Outcome Measures

Primary Outcomes (1)

  • Detection rate per Patient

    Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods.

    During surgery

Secondary Outcomes (3)

  • Number of lymph nodes excised

    During surgery

  • Nodal detection rate

    During surgery

  • Malignancy rate

    1-2 days post surgery

Study Arms (4)

Sienna+ retro and Technetium 1

ACTIVE COMPARATOR

Sienna+® is administered retro-mamillary 1 day before surgery for sentinel node marking. Technetium as standard technique is employed according to the gold standard protocol one day before surgery. The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.

Device: Sienna+ retroDevice: Technetium 1

Sienna+ peri and Technetium 1

ACTIVE COMPARATOR

Sienna+® is administered peri-tumorally 1 day before surgery for sentinel node marking. Technetium as standard technique is employed according to the gold standard protocol one day before surgery. The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.

Device: Sienna+ periDevice: Technetium 1

Sienna+ retro 4-6 and Technetium 1

ACTIVE COMPARATOR

Sienna+® is administered retro-mamillary 4-6 days before surgery for sentinel node marking. Technetium as standard technique is employed according to the gold standard protocol one day before surgery. The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.

Device: Sienna+ retro 4-6Device: Technetium 1

Sienna+ peri 4-6 and Technetium 1

ACTIVE COMPARATOR

Sienna+® is administered peri-tumorally 4-6 days before surgery for sentinel node marking. Technetium as standard technique is employed according to the gold standard protocol one day before surgery. The Sentimag device is used during surgery to detect the lymph nodes in parallel to the standard technique.

Device: Sienna+ peri 4-6Device: Technetium 1

Interventions

Sienna+ retroDEVICE

Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery

Sienna+ retro and Technetium 1
Sienna+ periDEVICE

Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery

Sienna+ peri and Technetium 1
Sienna+ retro 4-6DEVICE

Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery

Sienna+ retro 4-6 and Technetium 1
Sienna+ peri 4-6DEVICE

Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery

Sienna+ peri 4-6 and Technetium 1
Technetium 1DEVICE

Sentinel node marking with Technetium 1 day before surgery

Sienna+ peri 4-6 and Technetium 1Sienna+ peri and Technetium 1Sienna+ retro 4-6 and Technetium 1Sienna+ retro and Technetium 1

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has a diagnosis of primary breast cancer
  • Subject has been scheduled for surgery with a sentinel lymph node biopsy procedure
  • Subject is ≥18 years old at time of consent
  • Subject has an ECOG performance status of Grade 0-2
  • Subject has a clinical negative node status
  • Subject is available for the follow-up

You may not qualify if:

  • Subject is pregnant or lactating
  • Subject has a radiological evidence of metastatic cancer
  • Subject has had previous axilla surgery or reduction mammoplasty
  • Subject has impaired lymphatic function
  • Subject has had a preoperative radiation therapy
  • Subject has iron overload disease or iron/dextran intolerance
  • Subject has a pacemaker
  • Subject is under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kantonsspital Baden

Baden, 5404, Switzerland

Location

Inselspital Bern, Universitätsklinik für Frauen.

Bern, 3010, Switzerland

Location

Related Publications (4)

  • Thill M, Kurylcio A, Welter R, van Haasteren V, Grosse B, Berclaz G, Polkowski W, Hauser N. The Central-European SentiMag study: sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast. 2014 Apr;23(2):175-9. doi: 10.1016/j.breast.2014.01.004. Epub 2014 Jan 29.

    PMID: 24484967RESULT

  • Douek M, Klaase J, Monypenny I, Kothari A, Zechmeister K, Brown D, Wyld L, Drew P, Garmo H, Agbaje O, Pankhurst Q, Anninga B, Grootendorst M, Ten Haken B, Hall-Craggs MA, Purushotham A, Pinder S; SentiMAG Trialists Group. Sentinel node biopsy using a magnetic tracer versus standard technique: the SentiMAG Multicentre Trial. Ann Surg Oncol. 2014 Apr;21(4):1237-45. doi: 10.1245/s10434-013-3379-6. Epub 2013 Dec 10.

    PMID: 24322530RESULT

  • Ghilli M, Carretta E, Di Filippo F, Battaglia C, Fustaino L, Galanou I, Di Filippo S, Rucci P, Fantini MP, Roncella M. The superparamagnetic iron oxide tracer: a valid alternative in sentinel node biopsy for breast cancer treatment. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12385. Epub 2015 Sep 14.

    PMID: 26365441RESULT

  • Rubio IT, Diaz-Botero S, Esgueva A, Rodriguez R, Cortadellas T, Cordoba O, Espinosa-Bravo M. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol. 2015 Jan;41(1):46-51. doi: 10.1016/j.ejso.2014.11.006. Epub 2014 Nov 15.

    PMID: 25466980RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Nik Hauser, PD Dr.

    Kantonsspital Baden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nik Hauser, PD Dr.

CONTACT

+41 56 486 36 36brustzentrum@ksb.ch

Cornelia Leo, PD Dr. med.

CONTACT

+41 56 486 36 36brustzentrum@ksb.ch

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Department of Gynecology and Obstetrics

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 24, 2015

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 24, 2015

Record last verified: 2015-11

Locations

CH(2)