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SentiNeo2: Lymph Node Identification Using Magtrace and Magseed Before Chemotherapy

Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06104371
Collaborator
Uppsala University (Other), Region Västmanland (Other), University Hospital, Linkoeping (Other), Baylor College of Medicine (Other), The University of Hong Kong-Shenzhen Hospital (Other), Royal Marsden NHS Foundation Trust (Other), University of Athens (Other), University College Dublin (Other)
459
Enrollment
1
Location
61
Anticipated Duration (Months)
7.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Magnetic tracer injected before preoperative chemotherapy in breast cancer patients for sentinel lymph node detection. Also, magnetic tracer in combination with magnetic clip for index node identification.

Condition or Disease Intervention/Treatment Phase
  • Device: Magtrace

Detailed Description

This is an interventional single arm study. The aim is to see if sentinel lymph nodes marked with a magnetic tracer injected before preoperative chemotherapy can be detected at surgery three to six moths later. We also want to see if we find the same nodes with a tracer injected before chemotherapy as with a tracer injected after chemotherapy. The hypothesis is that the chemotherapy might affect the lymph drainage and the nodes marked before the chemptherapy are the true sentinel lymph nodes.

Furthermore, in patients with known lymph node metastases before chemotherapy one metastasis is marked with a magnetic clip before the chemotherapy. This isa well known method but it has not been done in combination with the magnetic tracer. We will show that this is feasible.

All patients included in the study will receive their treatments according to the current standard national guidelines as both the magnetic tracer and the routinely used radioactive tracer are used in parallell. The magnetic clip is also used at several sites in Sweden today.

Study Design

Study Type:
Observational
Anticipated Enrollment :
459 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Axillary Lymph Node Identification Before Neoadjuvant Chemotherapy Using Magtrace, (Superparamagnetic Iron Oxide Nanoparticles, SPIO) and Magseed, in Clinically Node Negative and Node Positive Patients. SentiNeo 2.0
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2027
Anticipated Study Completion Date :
Dec 31, 2028

Arms and Interventions

Arm Intervention/Treatment
Node negative

Clinically node negative before neoadjuvant chemotherapy

Device: Magtrace
Sentinel lymph node tracer and metastatic lymph node clip
Other Names:
  • Magseed

    		•
    Node positive

    Clinically node positive before neoadjuvant chemotherapy

    Device: Magtrace
    Sentinel lymph node tracer and metastatic lymph node clip
    Other Names:
  • Magseed

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sentinel lymph node detection rate [Perioperatively]

      per patient

    Secondary Outcome Measures

    1. Number of sentinel lymph nodes detected per tracer [Perioperatively]

      per node

    2. Concordance of nodes per tracer [Perioperatively]

      Ratio

    Eligibility Criteria

    Criteria

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

    Patients 18 years of age or older. Patients with breast cancer planned to undergo NACT with

    1. planned sentinel lymph node dissection (SLND), or

    2. targeted axillary lymph node dissection (TAD), in conjunction with the breast surgery after NACT.

    Exclusion Criteria:

    Intolerance / hypersensitivity to iron or dextran compounds or SPIO. Patients who are required to undergo MRI to evaluate tumour response. Pregnancy or breast feedin.g Patients with an iron overload disease. Patient deprived of liberty or under guardianship. Inability to understand given information and give informed consent or undergo study procedure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sahlgrenska University Hospital Gothenburg Sweden 413 45

    Sponsors and Collaborators

    • Sahlgrenska University Hospital, Sweden
    • Uppsala University
    • Region Västmanland
    • University Hospital, Linkoeping
    • Baylor College of Medicine
    • The University of Hong Kong-Shenzhen Hospital
    • Royal Marsden NHS Foundation Trust
    • University of Athens
    • University College Dublin

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Roger Olofsson Bagge, MD, PhD, professor, Sahlgrenska University Hospital, Sweden
    ClinicalTrials.gov Identifier:
    NCT06104371
    Other Study ID Numbers:
    • SUGBG-2023002
    First Posted:
    Oct 27, 2023
    Last Update Posted:
    Oct 27, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Roger Olofsson Bagge, MD, PhD, professor, Sahlgrenska University Hospital, Sweden
    sentinel lymph node detection
    neoadjuvant chemotherapy

    Study Results

    No Results Posted as of Oct 27, 2023