NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Head and neck cancer
Date of first enrollment	02/12/2025
Target sample size	15
Countries of recruitment
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