Detection of the sentinel lymph node in oral cancer using iron oxide nanoparticles, MRI and a magnetometer: a pilot study.

Completed

Conditions: oral cancer
10019190

Registration Number: NL-OMON48567

Lead Sponsor: niversiteit Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Patients diagnosed with T1-T2 oral cancer scheduled for END and who have
clinically and radiologically at maximum cN1, <15mm and not contains necrotic
tissue;
- Willing to & able to write informed consent from the subject prior to
participation.
- Willing to & capable of following study procedures
- Is older than 18 years
- Speaks and understand the Dutch language

Exclusion Criteria

- Positive result of ultrasound fine needle aspiration, for nodes >15mm and/or
necrotic tissue;
- Intolerance/ hypersensitivity to iron or dextran compounds or Sienna+;
- Intolerance/ hypersensitivity to lidocaine;
- Patients with an iron overload disease;
- Patients with non-palpable malignancies;
- Pregnant patients;
- Patients with pacemakers or other implantable devices in the upper body.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* The proportion of patients in which the SLNs could be detected (detection<br /><br>rate) using the magnetic method.<br /><br>* The proportion of sentinel nodes detected per patient during the SNB (in<br /><br>vivo) and after END, thus excised specimen (ex vivo).<br /><br>* The false-negative rate of detected SLNs based on the histopathological<br /><br>analysis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* The proportion of sentinel nodes which could be localized per patient on the<br /><br>MRI;<br /><br>* Estimation of maximal distance needed to detect Sienna signal by SentiMag;<br /><br>* SNB duration/ total duration time.</p><br>