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Sentinel lymph node localization of oral cancer using magnetic detection.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27348
Enrollment
10
Registered
2017-12-06
Start date
2018-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sentinel node biopsy (SNB), sentinel lymph node (SLN), oral cancer, magnetic detection. DUTCH: poortwachterklier procedure, mondholte kanker, magnetische detectie

Interventions

Peritumoral injection of SPIO, after Xillocaïne spray, and followed by an MRI to localize the SLN, the day before surgery. Also trancutaneous detection of trapped SPIO in SLN will be performed using a

Sponsors

University of Twente
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To investigate the feasibility of the magnetic approach in detection of the SLNs during SNB in the neck of patients with T1-T2 cancer

Secondary

MeasureTime frame
- Detectionrate - Compare results of MRI, surgery and pathology.

Contacts

Public ContactE.R. Nieuwenhuis

Magnetic Detection & Imaging group, University of Twente

e.r.nieuwenhuis@utwente.nl+31534891351

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)