Superparamagnetic iron oxide-enhanced magnetic resonance imaging for sentinel lymph node identification in oral cancer: a feasibility study

Phase 2

Completed

• Conditions: oral cancer; Oral cavity carcinoma; 10027656

• Registration Number: NL-OMON51046
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Male or female aged >18 years.
- Patients with histopathologically proven cT1-2N0M0 squamous cell carcinoma of
the oral cavity.
- Patients planned to undergo routine sentinel node biopsy with
99mTc-radioisotope and SPECT-CT.
- Patient provided written informed consent.

Exclusion Criteria

Patients who underwent previous surgery or radiotherapy to the neck.

Contra-indications to SPIO:
- prior allergic reaction to SPIO or any other iron preparation
- prior allergic reaction contributed to dextran or other polysaccharide, in
any preparation
- prior allergic reaction to contrast media of anytype
- hereditary hemochromatosis, thalassemia, sickle cell anemia

Patients unable to provide informed consent.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility of SPIO-enhanced MRI for SN detection in oral cancer patients:<br /><br>- To optimize dose of SPIO injection<br /><br>- To optimize the timing of MRI<br /><br>- To assess whether SNs detected by conventional 99mTC-nanocollloid injection<br /><br>and SPECT-CT are concordant with those visualized by SPIO injection and MRI</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess the distribution of SPIO within a lymph node by comparing in vivo<br /><br>MR-images and histopathological staining</p><br>