Trials / Unknown
UnknownNCT06261983
Magnetic Localization of Sentinel Nodes in Squamous Cell Oral Carcinoma.
Diagnostic Value of Sentinel Node Biopsy Guided by Magnetic Probe in Squamous Cell Oral Carcinoma: a Prospective Observational Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 24 (estimated)
- Sponsor
- Hospital Donostia · Academic / Other
- Sex
- All
- Age
- 29 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
Sentinel node biopsy has been shown to be a viable alternative to elective neck dissection in the early stages of squamous cell oral carcinoma. The aim of this study was to describe the magnetic localization of sentinel nodes (SN) after peritumoral injection of superparamagnetic iron oxide (SPIO) for treating this type of tumor and to analyze the technique's diagnostic performance in 23 patients. The technique located SNs (with minimal complication) in 95.6 % (22/23) of the patients. Three relapses occurred, one in a patient who had shown negative in magnetic SN location and elective neck dissection. The diagnostic performance of magnetic localization achieved a sensitivity and negative predictive value of 0.80 y 0.94, respectively. Magnetic localization of SNs has been shown to be a reproducible technique that may offer a viable alternative to the conventional technique.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Sentinel node biopsy guided by magnetic probe | Sentinel nodes exeresis guided by magnetic probe after injection submucosally and peritumorally of super-para-magnetic contrast. Standard neck dissection (levels I-II) were carry out after sentinel node biopsy |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2024-02-15
- Last updated
- 2024-02-15
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT06261983. Inclusion in this directory is not an endorsement.