Breast Cancer Clinical Trial
— MAGSNOWOfficial title:
Sentinel Node Localization and Staging With Low Dose Superparamagnetic Iron Oxide-enhanced Magnetic Resonance Imaging and Magnetic Probe in Patients With Breast Cancer
Verified date | January 2024 |
Source | Vastra Gotaland Region |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Sweden | Sahlgrenska University Hospital | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Vastra Gotaland Region |
Sweden,
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
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 |
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