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Trial record 4 of 25 for:    Feridex

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

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ClinicalTrials.gov Identifier: NCT02249208
Recruitment Status : Unknown
Verified September 2014 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
First Posted : September 25, 2014
Last Update Posted : September 30, 2014
Sponsor:
Collaborator:
Sysmex España S.L.
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

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 Type : Interventional  (Clinical Trial)
Estimated 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 : April 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. False Negative Rate [ Time Frame: 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 [ Time Frame: 3 months ]
    The Proportion of patients that SLNs was identified compared to total ALND patients.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02249208


Contacts
Contact: Isabel T Rubio, MD. PhD. irubio@vhio.net

Locations
Spain
Hospital Universitario Vall D Hebron. Recruiting
Barcelona, Spain, 08035
Principal Investigator: Isabel T Rubio, MD. PhD.         
Sub-Investigator: Martin Espinosa-Bravo, MD. PhD.         
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.

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02249208     History of Changes
Other Study ID Numbers: SENTINAC-01
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases