NCT05359783

Sentinel Node Localization and Staging with Low Dose Superparamagnetic Iron Oxide

Sentinel Node Localization and Staging with Low Dose Superparamagnetic Iron Oxide-enhanced Magnetic Resonance Imaging and Magnetic Probe in Patients with Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Sentinel Lymph Node

Interventions

Type	Name	Description
DRUG	Superparamagnetic Iron Oxide	Superparamagnetic iron oxide (SPIO) consists of an iron oxide nanoparticle core and a hydrophilic coating to make it biocompatible and colloidal stable in a suspension.

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-02-15
• Completion: 2024-04-30
• First posted: 2022-05-04
• Last updated: 2025-03-28

Locations

1 site across 1 country: Sweden