Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide for Breast Cancer Patients After Neoadjuvant Treatment.

Breast Cancer Clinical Trial

— SENTINAC-01  

Official title:

Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide vs. Standard Technique After Neoadjuvant Chemotherapy in Patients With Node-Positive Breast Cancer. A Randomized Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02249208
• Other study ID #: SENTINAC-01
• Status: Recruiting
• Phase: Phase 3
• First received: September 18, 2014
• Last updated: September 29, 2014
• Start date: April 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2014
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Isabel T Rubio, MD. PhD.
• Email: irubio[@]vhio.net
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencySpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the detection rate and the false negative rate of sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to radioisotope and compared to the standard method (blue and radioisotope) after neoadjuvant chemotherapy in patients with node-positive breast cancer converted to node negative after treatment by ultrasound. A randomized controlled trial.

Description:

Identification of Sentinel node:

• Arm 1 (Tc+blue dye): Identification of SLN using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and vital blue dye before surgery.

• Arm 2 (Tc+SPIO): Identification of SLN using standard isotope technique of sub-areolar injection of technetium-99m (Tc-99m) before surgery and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag® probe. (Study)

• Arm 3 (SPIO alone): Identification of SLN using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag® probe. (Study)

Sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown), detection guided by hand probe gamma radiation, colorimetric and / or and SentiMag® paramagnetic probe.

Lymph nodes that are radioactive, blue, magnetic or palpable are considered SLNs and are resected and submitted for pathological analysis. The protocol required that at least 2 SLNs to be resected.

In all cases a completion axillary lymphadenectomy nodes dissection (ALND) will be performed after SLN biopsy. All SLNs will be excised and submitted before performing the ALND.

Characterization of the nodal status of patients with the detection rate and the false negative rate of SLN for each arm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Histologically proven primary invasive breast cancer with clinical stage T1 through T3, N1 through N2, M0 according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, seventh edition

• Completed or were planning to undergo neoadjuvant chemotherapy

• Prechemotherapy axillary nodal disease confirmed by fine-needle aspiration or core-needle biopsy

• The axilla is clinically and radiologically (by ultrasound) negative (ycN0) postchemotherapy and before surgery

• Removal of at least two SLNs

• Signed informed consent from each patient before study entry

Exclusion Criteria:

• T4 tumors, cN3 or cM1

• The axilla is clinically and radiologically (by ultrasound) positive (ycN1) postchemotherapy

• Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to vital blue dye or radioactive product.

• Chronic iron overload

• Pacemaker or other metallic implantable device in the chest wall

• Failure to submit to medical study for geographical, social or psychological

• Patient deprived of liberty or under guardianship

• Pregnant or lactating

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Tc+blue dye
Sentinel Lymph Node (SLN) identification and resection using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and sub-areolar injection of vital blue dye before surgery
• Tc+SPIO
Sentinel Lymph Node (SLN) identification and resection using isotope technique of sub-areolar injection of technetium-99m (Tc-99m) and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®), before surgery
• SPIO alone
Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery

Locations

Country	Name	City	State
Spain	Hospital Universitario Vall D Hebron.	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Sysmex España S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	False Negative Rate	The proportion of number of patients with a negative SLN biopsy with the number of patients with axillary lymph node metastases.	3 months	Yes
Secondary	Detection Rate	The Proportion of patients that SLNs was identified compared to total ALND patients.	3 months	Yes