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

NCT06273501 | Enrolling By Invitation

• 1 other identifier: D-NR 2022-02876-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvar Cancer; Lymph Node Metastasis

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Magtrace DRUG

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 Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Department of Obstetrics and gynecology

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Vulvar Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Henrik Leonhardt

  Department of radiology, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 22, 2024
• Study Start: March 24, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)