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

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

NCT ID: NCT06273501

Condition: Vulvar Cancer
Lymph Node Metastasis

Conditions: Official terms:
Lymphatic Metastasis
Vulvar Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Magtrace
Description: 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.

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.

Criteria for 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

Gender: Female

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of Obstetrics and gynecology

Address:
City: Gothenburg
Zip: 41345
Country: Sweden

Start date: March 24, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Sahlgrenska University Hospital, Sweden
Agency class: Other

Source: Sahlgrenska University Hospital, Sweden

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06273501