Sentinel Node Localization and Staging With Low Dose Superparamagnetic Iron Oxide

• Status: Active, not recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.