Sentinel Node Localization and Staging with Low Dose Superparamagnetic Iron Oxide

Phase 1

Completed

• Conditions: Breast Cancer; Sentinel Lymph Node
• Interventions: Drug: Superparamagnetic Iron Oxide

• Registration Number: NCT05359783
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

Sentinel lymph node (SLN) status is pivotal for treatment decisions in breast cancer patients. The dual technique with Technetium99m (Tc99) and blue dye (BD) is yet the current routine for SLN detection. However, the same reliability has been presented by superparamagnetic iron oxide nanoparticles (SPIO). The aim of this study was to determine if SLN detection using ultra-low dose SPIO is feasible.

Detailed Description

Sentinel lymph node (SLN) status is pivotal for treatment decisions in breast cancer patients. The dual technique with Technetium99m (Tc99) and blue dye (BD) is yet the current routine for SLN detection. However, the same reliability has been presented by superparamagnetic iron oxide nanoparticles (SPIO). The aim of this study was to determine if SLN detection using ultra-low dose SPIO is feasible.

This is a phase Ib/II interventional dose-escalation single arm study. There will be a dose escalation of SPIO (0.1ml, 0.25ml and 0.5 ml) with a minimum of 5 patients per step. If 4 or more procedures are successful, no further dose escalation will be performed. 30 patients will be included with the minimal successful dose.

Furthermore, a total of 20 patients with the minimal successful dose will be included for the secondary objective A - to evaluate if it is possible to map and stage sentinel lymph nodes with SPIO-enhanced axillary MRI. For the secondary objective B - an additional of 20 patients with the minimal successful dose will be included to evaluate if SPIO in a low dose creates any SPIO related artifacts on breast MRI after breast conserving surgery. These two parts of the study are optional, and the patients will be asked specifically about participation in these two objectives, A and B. All included patients will be evaluated for skin staining at study visits.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-04
• Primary Completion: 2023-02-15
• Study Completion: 2024-04-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Female aged above 18 years
2. Signed and dated written informed consent before the start of specific protocol procedures
3. Histologically confirmed breast cancer planned for breast conserving surgery and sentinel lymph node biopsy

Exclusion Criteria

1. Pregnant or breast-feeding
2. Iron overload disease
3. Known hypersensitivity to iron, dextran compounds or blue dye.
4. Inability to understand given information and give informed consent or undergo study procedures
5. MRI (subgroup of patients): Conditions contraindicating MRI including, but not limited to, BMI > 40 kg/m2, claustrophobia, metallic implants or internal electrical devices (e.g., pacemaker) and permanent makeup or tattoos which in the Investigator's opinion might jeopardise the patient's safety or imaging.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sentinel node detection with 0.1mL SPIO	Superparamagnetic Iron Oxide	An intradermal injection of SPIO (MagTrace®), according to the pre-specified dose of 0.1mL, will be performed 7 days, up to the day of surgery. The injection should be in the skin over the tumour, or at the border of the areola

Primary Outcome Measures

Name	Time	Method
Sentinel lymph node detection rate compared to Tc99m and blue dye	During the procedure	To evaluate the use of superparamagnetic iron oxide (SPIO) as a tracer in a minimal lower dose (0.1-0.5 ml) for sentinel lymph node detection in breast cancer.

Secondary Outcome Measures

Name	Time	Method
MRI artefacts in breast	6 and 12 months after surgery	To evaluate if SPIO in a low dose creates any SPIO related breast MRI artefacts (assessed by breast MRI), reported as percentage of patients with artefacts present.
SPIO related skin staining	6 and 12 months after surgery	To evaluate if SPIO in a low dose creates any SPIO related skin staining (assessed by photo), reported as percentage of patients with artefacts present.

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden