Sentinel Node Localization and Staging With Low Dose Superparamagnetic Iron Oxide

Breast Cancer Clinical Trial

— MAGSNOW  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05359783
• Other study ID #: SUGBG-2021001
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 1, 2021
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 30, 2024
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

Intervention

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.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & Publications (6)

Jazrawi A, Pantiora E, Abdsaleh S, Bacovia DV, Eriksson S, Leonhardt H, Warnberg F, Karakatsanis A. Magnetic-Guided Axillary UltraSound (MagUS) Sentinel Lymph Node Biopsy and Mapping in Patients with Early Breast Cancer. A Phase 2, Single-Arm Prospective Clinical Trial. Cancers (Basel). 2021 Aug 25;13(17):4285. doi: 10.3390/cancers13174285. — View Citation

Karakatsanis A, Christiansen PM, Fischer L, Hedin C, Pistioli L, Sund M, Rasmussen NR, Jornsgard H, Tegnelius D, Eriksson S, Daskalakis K, Warnberg F, Markopoulos CJ, Bergkvist L. The Nordic SentiMag trial: a comparison of super paramagnetic iron oxide (SPIO) nanoparticles versus Tc(99) and patent blue in the detection of sentinel node (SN) in patients with breast cancer and a meta-analysis of earlier studies. Breast Cancer Res Treat. 2016 Jun;157(2):281-294. doi: 10.1007/s10549-016-3809-9. Epub 2016 Apr 27. — View Citation

Karakatsanis A, Daskalakis K, Stalberg P, Olofsson H, Andersson Y, Eriksson S, Bergkvist L, Warnberg F. Superparamagnetic iron oxide nanoparticles as the sole method for sentinel node biopsy detection in patients with breast cancer. Br J Surg. 2017 Nov;104(12):1675-1685. doi: 10.1002/bjs.10606. Epub 2017 Sep 6. — View Citation

Motomura K, Izumi T, Tateishi S, Sumino H, Noguchi A, Horinouchi T, Nakanishi K. Correlation between the area of high-signal intensity on SPIO-enhanced MR imaging and the pathologic size of sentinel node metastases in breast cancer patients with positive sentinel nodes. BMC Med Imaging. 2013 Sep 13;13:32. doi: 10.1186/1471-2342-13-32. — View Citation

Motomura K, Izumi T, Tateishi S, Tamaki Y, Ito Y, Horinouchi T, Nakanishi K. Superparamagnetic iron oxide-enhanced MRI at 3 T for accurate axillary staging in breast cancer. Br J Surg. 2016 Jan;103(1):60-9. doi: 10.1002/bjs.10040. Epub 2015 Nov 17. — View Citation

Waanders S, Visscher M, Wildeboer RR, Oderkerk TO, Krooshoop HJ, Ten Haken B. A handheld SPIO-based sentinel lymph node mapping device using differential magnetometry. Phys Med Biol. 2016 Nov 21;61(22):8120-8134. doi: 10.1088/0031-9155/61/22/8120. Epub 2016 Oct 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During the procedure
Secondary	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.	6 and 12 months after surgery
Secondary	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.	6 and 12 months after surgery