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

Vulvar Cancer Clinical Trial

— POSVUC  

Official title:

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06273501
• Other study ID #: D-NR 2022-02876-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 24, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymph Node Metastasis
• Lymphatic Metastasis
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Sweden	Department of Obstetrics and gynecology	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 30 days after SPIO injection.