MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer

N/AEnrolling By InvitationNCT06273501

Sahlgrenska University Hospital20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Vulvar Cancer Lymph Node Metastasis

Interventions

MagtraceDRUG

Patients will receive superficial and interstitial injection with a 23 G needle with of a total volume of 0.1 - 1 ml Magtrace at four sites in or near the tumor in vulva, the same localization as the injections of Technetium99m and Patent blue for tracing SLNs performed at the surgery. The injection is performed by one of the gynecologic cancer surgeons participating in this study.The time of migration of SPIO to the groin nodes is not known for vulvar cancer. Transportation by dynamic MRI, with selective sequences repeated during a time span of 1- 60 minutes after the injection.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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 4. Known hypersensitivity to iron or dextran compounds Inability to understand given information and give informed consent or undergo study procedure

Locations (1)

Department of Obstetrics and gynecology

Gothenburg, Sweden

Outcomes

Primary Outcomes

Sentinel lymph node identification

The number of lymph nodes identified preoperatively with SPIO-enhanced MRI and intraoperatively with a magnetometer compared to Technetium-99m scintigraphy and blue dye.

Time frame: Within 30 days after SPIO injection.

Data from ClinicalTrials.gov

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