Sienna+® Injection Time Study 4 Arms

Kantonsspital Baden40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Neoplasms

Interventions

Sienna+ retroDEVICE

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

Sienna+ periDEVICE

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

Sienna+ retro 4-6DEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (2)

Kantonsspital Baden

Baden, Switzerland

Inselspital Bern, Universitätsklinik für Frauen.

Bern, Switzerland

Outcomes

Primary Outcomes

Detection rate per Patient

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

Time frame: During surgery

Secondary Outcomes

Number of lymph nodes excised

Number of excised sentinel lymph nodes

Time frame: During surgery

Nodal detection rate

Number of detected versus excised sentinel lymph nodes with either method.

Time frame: During surgery

Malignancy rate

Number of histologically confirmed malignant sentinel lymph nodes detected with either method.

Time frame: 1-2 days post surgery

Central Contacts

Nik Hauser, PD Dr.

CONTACT

+41 56 486 36 36 brustzentrum@ksb.ch

Cornelia Leo, PD Dr. med.

CONTACT

+41 56 486 36 36 brustzentrum@ksb.ch

Data from ClinicalTrials.gov

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