Preoperative MRI and Magnetometer-guided Intraoperative Sentinel Lymph Node Detection With Superparamagnetic Iron Oxide Nanoparticles (SPIO) in Patients With Vulvar Cancer - a Feasibility Study (POSVUC Pilot)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vulvar Cancer
- Sponsor
- Sahlgrenska University Hospital, Sweden
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Sentinel lymph node identification
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
Brief Summary
The aim of the feasibility study is to evaluate whether SPIO-MRI and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative SLN localization. Secondary, to explore if SPIO-MRI could predict lymph node status in comparison to histopathological analysis.
Detailed Description
Sentinel lymph node (SLN) biopsy is the routine procedure for nodal staging in early vulvar squamous cell carcinoma (VSCC) in the absence of clinical signs of lymph node metastasis. The gold standard technique for identifying SLN utilizes Technetium (Tc99m) lymphoscintigraphy and blue dye. An alternative method has emerged using superparamagnetic iron-oxide (SPIO) and magnetic resonance imaging (MRI). This study aims to enroll 20 VSCC patients scheduled for the SLN procedure. Determination of the minimal dosage of SPIO required to avoid excessive MRI artifacts while still identifying the SLN. Intraoperative SLN detection with a magnetometer will be compared with the gold standard gamma probe. As secondary objective, in addition to determining the SNL, MRI analysis of the nodal status will be evaluated for potential metastasis and compared to histopathological results.
Investigators
Katja Stenström Bohlin
Principal Investigator
Sahlgrenska University Hospital, Sweden
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed primary VSCC \<4 cm, candidates for surgery with SLNB Age above 18
- •Signed and dated written consent before the start of specific protocol procedures.
- •ECOG performance status 0-2
Exclusion Criteria
- •Contraindications for MRI such as electronic implants or severe claustrophobia
- •Hip replacement
- •Iron overload disease
- •Known hypersensitivity to iron or dextran compounds
- •Inability to understand given information and give informed consent or undergo study procedure
Outcomes
Primary Outcomes
Sentinel lymph node identification
Time Frame: Within 30 days after SPIO injection.
The number of lymph nodes identified preoperatively with SPIO-enhanced MRI and intraoperatively with a magnetometer compared to Technetium-99m scintigraphy and blue dye.