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Delayed SLND Tracing for Breast Cancer (SENTINOT_2 Trial)

Phase 3
Recruiting
Led By Andreas Karakatsanis, PhD
Research Sponsored by Uppsala University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a preoperative diagnosis of DCIS with suspicion of micro-invasion on core biopsy
Patients with a mammographic/ultrasound/MRI finding, suspicious for breast cancer (BIRADS 4 or 5) planned for diagnostic excision with breast conserving surgery, with no definitive diagnosis of invasive cancer
Must not have
Patient deprived of liberty or under guardianship
An iron overload disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Summary

This trial is investigating the use of superparamagnetic iron oxide nanoparticles as a tracer for delayed sentinel lymph node dissection in patients where upfront axillary surgery is oncologically deemed unnecessary.

Who is the study for?
This trial is for patients with a pre-diagnosis of ductal cancer in situ (DCIS) or suspicious breast lesions, who are undergoing procedures that might affect future sentinel lymph node detection. It's also open to those planning risk-reducing mastectomies or complex oncoplastic surgeries. Excluded are individuals with iron/dextran/SPIO hypersensitivity, iron overload diseases, pregnant/lactating women, and those deprived of liberty or under guardianship.Check my eligibility
What is being tested?
The study tests the use of superparamagnetic iron oxide nanoparticles as a tracer for delayed sentinel lymph node dissection in breast cancer cases where immediate axillary surgery isn't necessary. If invasive cancer is found after initial surgery, then an operation in the axilla follows.See study design
What are the potential side effects?
Potential side effects may include reactions related to intolerance to SPIO such as allergic reactions or issues due to excess iron from the nanoparticles used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was diagnosed with DCIS and there might be very small invasions.
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I am scheduled for a breast surgery due to a suspicious finding but don't have a confirmed cancer diagnosis.
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I have a high-grade or large pre-cancerous breast lesion and am planning to conserve my breast.
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I have been diagnosed with DCIS and am planning a complex breast surgery.
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I was diagnosed with DCIS and have a noticeable lump or mass effect.
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I am diagnosed with DCIS and planning a mastectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not under legal supervision or guardianship.
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I have a condition that causes too much iron in my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nodal concordance
d-SLND detection rate
l-SLND detection rate
Secondary outcome measures
Malignancy rate
Nodal Malignancy rate
Per patient concordance
+1 more
Other outcome measures
Breast Specific Health Related Quality of Life (HR-QoL)
Cost effectiveness
Disease free interval
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Delayed SLND (SPIO-first arm)Experimental Treatment1 Intervention
All study participants have been injected interstitially with SPIO, 2ml, at the primary operation. Magnetic axillary signal is registered at the end of the procedure but the SLN is not removed. If invasive cancer is found in the specimen, reoperation for SLND with the addition of Tc +/- BD is performed. At reoperation, SPIO is the "primary" detection tracer.
Group II: Late SLND (RI-first arm)Active Control1 Intervention
All study participants have been injected interstitially with SPIO, 2ml, at the primary operation. Magnetic axillary signal is registered at the end of the procedure but the SLN is not removed. If invasive cancer is found in the specimen, reoperation for SLND with the addition of Tc +/- BD is performed. At reoperation, Tc is the "primary" detection tracer.

Find a Location

Who is running the clinical trial?

Skane University HospitalOTHER
170 Previous Clinical Trials
88,587 Total Patients Enrolled
Sahlgrenska University Hospital, SwedenOTHER
423 Previous Clinical Trials
299,329 Total Patients Enrolled
6 Trials studying Breast Cancer
1,249 Patients Enrolled for Breast Cancer
Norrlands University HospitalOTHER
10 Previous Clinical Trials
2,378 Total Patients Enrolled

Media Library

Delayed SLND Clinical Trial Eligibility Overview. Trial Name: NCT04722692 — Phase 3
Breast Cancer Research Study Groups: Delayed SLND (SPIO-first arm), Late SLND (RI-first arm)
Breast Cancer Clinical Trial 2023: Delayed SLND Highlights & Side Effects. Trial Name: NCT04722692 — Phase 3
Delayed SLND 2023 Treatment Timeline for Medical Study. Trial Name: NCT04722692 — Phase 3
~179 spots leftby Dec 2026
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