Sentinel Node Localization and Staging with Low Dose Superparamagnetic Iron Oxide

Vastra Gotaland Region50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer Sentinel Lymph Node

Interventions

Superparamagnetic Iron OxideDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Outcomes

Primary Outcomes

Sentinel lymph node detection rate compared to Tc99m and blue dye

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.

Time frame: During the procedure

Secondary Outcomes

MRI artefacts in breast

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.

Time frame: 6 and 12 months after surgery

SPIO related skin staining

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.

Time frame: 6 and 12 months after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.