Sienna+® Injection Time Study 4 Arms

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Device: Sienna+ retro
* Device: Sienna+ peri
* Device: Sienna+ retro 4-6
* Device: Sienna+ peri 4-6
* Device: Technetium 1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sienna+ retro and Technetium 1<br>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+ retro<br>* Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery<br>Device: Technetium 1<br>* Sentinel node marking with Technetium 1 day before surgery<br>|
| Active Comparator: Sienna+ peri and Technetium 1<br>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+ peri<br>* Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery<br>Device: Technetium 1<br>* Sentinel node marking with Technetium 1 day before surgery<br>|
| Active Comparator: Sienna+ retro 4-6 and Technetium 1<br>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 4-6<br>* Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery<br>Device: Technetium 1<br>* Sentinel node marking with Technetium 1 day before surgery<br>|
| Active Comparator: Sienna+ peri 4-6 and Technetium 1<br>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 4-6<br>* Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery<br>Device: Technetium 1<br>* Sentinel node marking with Technetium 1 day before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Sentinel Node, Sentinel Node Biopsy, Breast Surgery