500 Participants Needed

Delayed SLND Tracing for Breast Cancer

(SENTINOT_2 Trial)

Recruiting at 8 trial locations
AK
FW
Overseen ByFredrik Wärnberg, PhD
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: Uppsala University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to investigate the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients where upfront axillary surgery (SLND) is oncologically deemed unnecessary and should be avoided. This includes but is not limited to patients with a preoperative diagnosis of ductal cancer in situ of the breast (DCIS), an unclear BIRADS 4-5 planned for diagnostic excision or women planned for risk reducing mastectomy. SPIO is injected in the primary operation, and should final specimen pathology demonstrate invasive breast cancer, only then is an operation in the axilla (d-SLND) performed.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is Delayed SLND Tracing for Breast Cancer safe for humans?

Studies using superparamagnetic iron oxide (SPIO) for sentinel lymph node biopsy in breast cancer patients have shown it to be safe, with no serious adverse events reported.12345

How does the Delayed SLND Tracing treatment for breast cancer differ from other treatments?

The Delayed SLND Tracing treatment for breast cancer uses superparamagnetic iron oxide (SPIO) nanoparticles as a tracer instead of the traditional radioisotopes and blue dye. This method is unique because it avoids radiation exposure and logistical challenges associated with radioisotopes, offering a non-invasive and effective alternative for identifying sentinel lymph nodes.12456

What data supports the effectiveness of the treatment Delayed Sentinel Lymph Node Biopsy, Delayed Sentinel Lymph Node Dissection, d-SLND, Superparamagnetic Iron Oxide (SPIO) Guided Sentinel Lymph Node Biopsy for breast cancer?

Research shows that using superparamagnetic iron oxide (SPIO) for sentinel lymph node biopsy in breast cancer is as effective as the traditional method using radioisotopes. Studies have found SPIO to be a safe and feasible alternative, with successful detection of sentinel nodes in all patients tested.12367

Who Is on the Research Team?

AK

Andreas Karakatsanis, PhD

Principal Investigator

Uppsala University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I was diagnosed with DCIS and there might be very small invasions.
I am scheduled for a breast surgery due to a suspicious finding but don't have a confirmed cancer diagnosis.
I was diagnosed with a specific type of non-invasive breast condition before surgery.
See 6 more

Exclusion Criteria

Pregnant or lactating patients
I am not under legal supervision or guardianship.
I have a condition that causes too much iron in my body.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Primary Operation

SPIO is injected up to 24 hours preoperatively or perioperatively during primary breast surgery

1 day
1 visit (in-person)

Delayed Sentinel Lymph Node Dissection (d-SLND)

If invasive cancer is found, reoperation for SLND with the addition of Tc +/- BD is performed

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Visits at 1, 6, and 12 months postoperatively

What Are the Treatments Tested in This Trial?

Interventions

  • Delayed Sentinel Lymph Node Biopsy
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Delayed SLND (SPIO-first arm)Experimental Treatment1 Intervention
Group II: Late SLND (RI-first arm)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Uppsala University

Lead Sponsor

Trials
529
Recruited
3,333,000+

Sahlgrenska University Hospital

Collaborator

Trials
519
Recruited
387,000+

Vastra Gotaland Region

Collaborator

Trials
689
Recruited
1,455,000+

Skane University Hospital

Collaborator

Trials
177
Recruited
98,800+

Sahlgrenska University Hospital, Sweden

Collaborator

Trials
439
Recruited
307,000+

Norrlands University Hospital

Collaborator

Trials
14
Recruited
9,800+

Dalarna County Hospital, Falun, Sweden

Collaborator

Trials
1
Recruited
500+

Västmanlands Hospital, Västerås, Sweden

Collaborator

Trials
2
Recruited
1,900+

University Hospital, Linkoeping

Collaborator

Trials
192
Recruited
967,000+

Blekinge County Council Hospital

Collaborator

Trials
16
Recruited
11,300+

Published Research Related to This Trial

The MONOS study demonstrated that superparamagnetic iron oxide (SPIO) nanoparticles are a safe and effective alternative to the standard radioisotope 99m Tc for sentinel node biopsy in breast cancer, with comparable detection rates (95.6% for SPIO vs. 96.9% for 99m Tc).
Preoperative injection of SPIO significantly improved tracer-specific detection rates and the number of nodes retrieved compared to perioperative injection, suggesting that this method simplifies logistics and enhances the efficacy of the procedure.
Superparamagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy detection in patients with breast cancer.Karakatsanis, A., Daskalakis, K., Stålberg, P., et al.[2022]
Superparamagnetic iron oxide (SPIO) combined with pre-operative MRI scanning effectively identifies sentinel lymph nodes (SLNs) in melanoma patients, showing promising results in a small study with 6 participants.
The most effective technique involved a 1.0 ml intracutaneous injection of SPIO followed by a two-minute massage, which successfully visualized SLNs in all participants within five minutes, suggesting a simpler and safer alternative to traditional methods.
Sentinel lymph node mapping with superparamagnetic iron oxide for melanoma: a pilot study in healthy participants to establish an optimal MRI workflow protocol.Aldenhoven, L., Frotscher, C., Körver-Steeman, R., et al.[2022]
In a study involving 74 female breast cancer patients who received neoadjuvant chemotherapy, superparamagnetic iron oxide (SPIO) was successfully used for sentinel lymph node biopsy, with all patients having detectable sentinel nodes.
The procedure was efficient, with a median lymph node retrieval time of 20 minutes and no serious adverse events reported, indicating that SPIO is a safe and effective alternative for nodal identification in this patient population.
Superparamagnetic Iron Oxide for Identifying Sentinel Lymph Node in Breast Cancer after Neoadjuvant Chemotherapy: Feasibility Study.Kurylcio, A., Pelc, Z., Skórzewska, M., et al.[2021]

Citations

Superparamagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy detection in patients with breast cancer. [2022]
Sentinel lymph node mapping with superparamagnetic iron oxide for melanoma: a pilot study in healthy participants to establish an optimal MRI workflow protocol. [2022]
Superparamagnetic Iron Oxide for Identifying Sentinel Lymph Node in Breast Cancer after Neoadjuvant Chemotherapy: Feasibility Study. [2021]
Use of Superparamagnetic Iron Oxide (SPIO) Versus Conventional Technique in Sentinel Lymph Node Detection for Breast Cancer: A Randomised Controlled Trial. [2023]
Pre-operative sentinel lymph node localization in breast cancer with superparamagnetic iron oxide MRI: the SentiMAG Multicentre Trial imaging subprotocol. [2022]
Magnetic resonance lymphography of sentinel lymph nodes in patients with breast cancer using superparamagnetic iron oxide: a feasibility study. [2016]
Sentinel Lymph Node Biopsy in Early Breast Cancer: Magnetic Tracer as the Only Localizing Agent. [2023]
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