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

Treatment method of lymph node metastasis by lymphatic drug delivery system-phase I study evaluating the safety of the method

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs021230040
Enrollment
15
Registered
2023-11-22
Start date
2025-12-02
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer head and neck cancer, lymph node metastasis

Interventions

puncture the targert metastatic lymph node guided under sonography and inject the anti-tumor agent adjusted for LDDS.

Sponsors

Katagiri Katsunori
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Histopathological evaluation of the treatment results for metastatic lymph nodes based on Oh-hoshi-Shimosato classification.

Contacts

Public ContactKatsunori Katagiri

Iwate Medical University

kkatagir@iwate-med.ac.jp+81-19-613-7111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026