Sienna+® Injection Time Study 4 Arms (Sentimag02)

Kantonsspital Baden

Status and phase: Unknown; Phase 4

Conditions: Breast Neoplasms

Treatments: Device: Technetium 1; Device: Sienna+ retro; Device: Sienna+ peri; Device: Sienna+ retro 4-6; Device: Sienna+ peri 4-6

Study type: Interventional

Funder types: Other

Identifiers

NCT02612870

Baden201512

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Sienna+ retro and Technetium 1

Active Comparator group

Description:

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.

Treatment:

Device: Sienna+ retro

Device: Technetium 1

Sienna+ peri and Technetium 1

Active Comparator group

Description:

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.

Treatment:

Device: Sienna+ peri

Device: Technetium 1

Sienna+ retro 4-6 and Technetium 1

Active Comparator group

Description:

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.

Treatment:

Device: Technetium 1

Device: Sienna+ retro 4-6

Sienna+ peri 4-6 and Technetium 1

Active Comparator group

Description:

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.

Treatment:

Device: Technetium 1

Device: Sienna+ peri 4-6