Sentinel Node Localization and Staging with Low Dose Superparamagnetic Iron Oxide

Launched by VASTRA GOTALAND REGION · Apr 28, 2022

Keywords

ClinConnect 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.

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 proc...

Gender

FEMALE

Eligibility criteria

• 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.