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

NCT06273501 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-02-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Henrik Leonhardt · Department of radiology, Sahlgrenska University Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2024-12-01
Completion
2024-12-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06273501 on ClinicalTrials.gov