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Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment

NCT05985551 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 114

Last updated 2024-05-03

No results posted yet for this study

Summary

The goal of this study was to assess the feasibility of SLND by superparamagnetic iron oxide nanoparticles (SPIO) in patients with early breast cancer planned for primary systemic therapy (PST) and whether this is affected by the timeframe of SPIO administration.

For this, patients with cN0/1 disease planned for PST received radioisotope as per routine on the day of surgery or the day before, and SPIO was injected in an extended timeframe, at any point from the day of surgery to before the induction of PST.

The main points to investigate are:

1. If the SPIO detection rate and concordance to the radiosotope are affected by time of SPIO injection
2. If the nodal yield and the accuracy of the procedure are affected

Conditions

Interventions

OTHER

SLND or TAD by the magnetic technique (SPIO)

All patients will receive Radioisotope according to standard of care. They will also receive SPIO in a timeframe of clinical convenience, depending on whether primary response is planned by means of MRI. For patients that are ycN0, SLND or TAD will be performed. For those that convert from cN1 to ycN0, the index lymph node will be marked with a paramagnetic marker. Axillary surgery will be undertaken with the magnetic technique and each retrieved lymph node will be controlled for radiation. Upon the completion of the procedure, a background control will be performed with the radioactive signal as guide, to ensure standard of care best practice. Any palpable lymph nodes that are not sentinels with either tracer may be removed at surgeon discretion but will be reported seperately.

Sponsors & Collaborators

  • Uppsala University Hospital

    collaborator OTHER

  • Uppsala University

    lead OTHER

Principal Investigators

  • Andreas U Karakatsanis, MD, PhD · Uppsala University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2026-10-30
Completion
2027-10-30

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05985551 on ClinicalTrials.gov