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

Phase 1

• Conditions: Head and neck cancer; head and neck cancer, lymph node metastasis; D000077195

• Registration Number: JPRN-jRCTs021230040
• Lead Sponsor: Shiga Kiyoto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-22
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 15

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Histopathological evaluation of the treatment results for metastatic lymph nodes based on Oh-hoshi-Shimosato classification.