Phase I study of the lymphatic drug delivery system (LDDS)

JRCT ID: jRCTs021230040

Registered date:22/11/2023

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Head and neck cancer
• Date of first enrollment: 22/11/2023
• Target sample size: 15
• Study type: Interventional
• Intervention(s): puncture the targert metastatic lymph node guided under sonography and inject the anti-tumor agent adjusted for LDDS.

Outcome(s)

• Primary Outcome: Frequencies of the adverse events such as complication and allergic response before and after the injection procedure of anti-tumor agent prepared for LDDS.
• Secondary Outcome: Histopathological evaluation of the treatment results for metastatic lymph nodes based on Oh-hoshi-Shimosato classification.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) diagnosed with head end neck cancer by histopathological or cytological examination and having lympn
node metastases in the neck.
2) neck dissection is planned
3) aged 18 or older
4) written informed consent is obtained by patients themselves

Exclude criteria

1) invasion of the cancer to the neck
2) alllergy to the drug used in this study
3) patients who are judged to be unsuitable for this study by the physician

Related Information

• Primary Sponsor: Shiga Kiyoto