SLNB using magnetic probe for oral cancer

JRCT ID: jRCTs031180198

Registered date:07/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Oral cancer
• Date of first enrollment: 15/02/2017
• Target sample size: 27
• Study type: Interventional

Intervention(s)

Superparamagnetic iron oxide (0.4 ml) is injected around oral cancer 1 day before surgery, and sentinel lymph node mapping is performed using MR lymphography.
During surgery, sentinel lymph node biopsy is performed using magnetic probe.

Outcome(s)

• Primary Outcome: Identification of sentinel lymph node
• Secondary Outcome: Metastasis of sentinel lymph node, occult cervical lymph node metastasis

Key inclusion & exclusion criteria

• Age minimum: 20 years of age or more
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Early stage oral cancer patients without cervical lymph node metastasis (T1-2N0). Untreated oral cancer patients. Written informed consent was obtained.
• Exclude criteria: Patients with allergy of iron or iodine agent, pregnancy, asthma, or renal dysfunction.

Related Information

• Primary Sponsor: Iwai Toshinori
• Source(s) of Monetary Support: Yokohama City University Hospital
• Secondary ID(s): UMIN000025426