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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

No Placebo-Only Group

Pivotal 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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nodal concordance

d-SLND detection rate

l-SLND detection rate

Secondary study objectives

Malignancy rate

Nodal Malignancy rate

Per patient concordance

+1 more

Other study objectives

Breast Specific Health Related Quality of Life (HR-QoL)

Cost effectiveness

Disease free interval

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 8Eligibility criteria met