← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

SENTINOT_2 Trial 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.

SENTINOT_2 Trial Eligibility Criteria

Inclusion Criteria

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

SENTINOT_2 Trial 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

SENTINOT_2 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
169 Previous Clinical Trials
86,394 Total Patients Enrolled
Sahlgrenska University Hospital, SwedenOTHER
417 Previous Clinical Trials
297,274 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals does this experiment aim to achieve?

"The primary outcome variable that will be assessed in this study is the l-SLND detection rate, which will be evaluated at a single time point (at operation). Secondary outcome measures include Per patient concordance, Malignancy rate, and Nodal Malignancy rate. Analyses will be performed cumulatively and +/-BD and per type of surgery (BCT or mastectomy)."

Answered by AI

Are there any anticipated risks associated with Delayed SLND?

"Given that this is a phase 3 trial with both efficacy and safety data, our team at Power has rated the safety of Delayed SLND as a 3."

Answered by AI

Are we still recruiting participants for this trial?

"That is correct. The clinical trial, which was posted on March 1st 2020 and updated on March 14th 2022, is still recruiting patients. They are looking for 500 individuals across 1 medical centre."

Answered by AI
~191 spots leftby Dec 2026