Sienna+® Injection Time Study 4 Arms

Sienna+® Injection Time Study: A Prospective Multicentre, Controlled Clinical Trial to Evaluate the Performance of Superparamagnetic Iron Oxide vs. Standard Technique as Tracer in Sentinel Node Biopsy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02612870

Acronym

Sentimag02

Enrollment

Registered

2015-11-24

Start date

2016-02-29

Completion date

2016-06-30

Last updated

2015-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Breast Cancer, Sentinel Node, Sentinel Node Biopsy, Breast Surgery

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.

Detailed description

Sienna+® is injected either 1 day or 4-6 days before surgery, either retro-mamillary or peri-tumorally: * Sienna+® retro-mamillary 1 day before surgery: 10 patients * Sienna+® peri-tumorally 1 day before surgery: 10 patients * Sienna+® retro-mamillary 4-6 days before surgery: 10 patients * Sienna+® peri-tumorally 4-6 days before surgery: 10 patients In each case, 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.

Interventions

DEVICESienna+ retro

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

DEVICESienna+ peri

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

DEVICESienna+ retro 4-6

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

DEVICESienna+ peri 4-6

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

DEVICETechnetium 1

Sentinel node marking with Technetium 1 day before surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Detection rate per Patient	During surgery	Proportion of successfully detected sentinel nodes (detection rate per patient) with both methods.

Secondary

Measure	Time frame	Description
Number of lymph nodes excised	During surgery	Number of excised sentinel lymph nodes
Nodal detection rate	During surgery	Number of detected versus excised sentinel lymph nodes with either method.
Malignancy rate	1-2 days post surgery	Number of histologically confirmed malignant sentinel lymph nodes detected with either method.

Countries

Switzerland

Contacts

Primary ContactNik Hauser, PD Dr.

brustzentrum@ksb.ch+41 56 486 36 36

Backup ContactCornelia Leo, PD Dr. med.