Status:
COMPLETED
Sentinel Node Localization and Staging with Low Dose Superparamagnetic Iron Oxide
Lead Sponsor:
Vastra Gotaland Region
Conditions:
Breast Cancer
Sentinel Lymph Node
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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 detecti...
Detailed 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 detecti...
Eligibility Criteria
Inclusion
- Female aged above 18 years
- Signed and dated written informed consent before the start of specific protocol procedures
- Histologically confirmed breast cancer planned for breast conserving surgery and sentinel lymph node biopsy
Exclusion
- Pregnant or breast-feeding
- Iron overload disease
- Known hypersensitivity to iron, dextran compounds or blue dye.
- Inability to understand given information and give informed consent or undergo study procedures
- 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.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05359783
Start Date
November 1 2021
End Date
April 30 2024
Last Update
March 28 2025
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345