SLNB using magnetic and RI methods for oral cancer

JRCT ID: jRCTs031220038

Registered date:25/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oral cancer
• Date of first enrollment: 24/01/2023
• Target sample size: 27
• Study type: Interventional
• Intervention(s): Superparamagnetic iron oxide and radioisotope are injected around oral cancer 1 day before surgery, and sentinel lymph node mapping is performed using MR lymphography and SPECT/CT. During surgery, sentinel lymph node biopsy is performed using magnetic and gannma probes.

Outcome(s)

• Primary Outcome: Detection rate of sentinel lymph node using magnetic and ganmma probes (Number of patients in whom all sentinel lymph nodes mapped on preoperative images were identified/ all patient number)
• Secondary Outcome: Detection rate of sentinel lymph node using magnetic and ganmma probes (Number of identified lymph node/ total number of mapped lymph node)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• 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 iron allergy or pregnancy.

Related Information

• Primary Sponsor: Iwai Toshinori Toshinori
• Source(s) of Monetary Support: Yokohama City Cancer Research Promotion