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

NCT ID: NCT06273501

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2024-12-31

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.

Conditions

Vulvar Cancer; Lymph Node Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Magtrace

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.

Intervention Type: DRUG

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 4. Known hypersensitivity to iron or dextran compounds

Inability to understand given information and give informed consent or undergo study procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Katja Stenström Bohlin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henrik Leonhardt

Role: PRINCIPAL_INVESTIGATOR

Department of radiology, Sahlgrenska University Hospital

Locations

Department of Obstetrics and gynecology

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

D-NR 2022-02876-01

Identifier Type: -

Identifier Source: org_study_id