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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06273501
Other study ID # D-NR 2022-02876-01
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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.
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