SENTINAC-01: Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide for Breast Cancer Patients After Neoadjuvant Treatment.

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02249208
• Collaborator: Sysmex España S.L. (Industry)
• Enrollment: 150
• Location: 1
• Arms: 3
• Duration (Months): 26
• Patients Per Site Per Month: 5.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: Tc+blue dye; Device: Tc+SPIO; Device: SPIO alone	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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.
• Study Start Date: Apr 1, 2014
• Anticipated Primary Completion Date: Jun 1, 2016
• Anticipated Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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
Experimental: 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.	Device: 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
Experimental: SPIO alone Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery.	Device: SPIO alone; Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery

Outcome Measures

Primary Outcome Measures

1. False Negative Rate [3 months]

   The proportion of number of patients with a negative SLN biopsy with the number of patients with axillary lymph node metastases.

Secondary Outcome Measures

1. Detection Rate [3 months]

   The Proportion of patients that SLNs was identified compared to total ALND patients.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Vall D Hebron.	Barcelona		Spain	08035

Sponsors and Collaborators

• Hospital Universitari Vall d'Hebron Research Institute
• Sysmex España S.L.

Investigators

• Study Director: Isabel T Rubio, MD. PhD., Hospital Universitario Vall D Hebron. Universidad Autónoma de Barcelona.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
• ClinicalTrials.gov Identifier: NCT02249208
• Other Study ID Numbers: SENTINAC-01
• First Posted: Sep 25, 2014
• Last Update Posted: Sep 30, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Hospital Universitari Vall d'Hebron Research Institute: Breast Cancer; Sentinel Lymph Node; Neoadjuvant Chemotherapy; Clinically Node-Positive with biopsy-proven cN1; False-negative Rate
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

No Results Posted as of Sep 30, 2014