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A research study to look at how methylene blue dye can help doctors find the lymph nodes in the neck for people with oral cancers.

A Prospective Observational Study on Neck Lymph Node Mapping in Oral Cancers Using Methylene Blue Dye

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/07/055447
Enrollment
45
Registered
2023-07-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: C068- Malignant neoplasm of overlappingsites of other and unspecified parts of mouth

Interventions

None listed

Sponsors

Dr Chiranjit Mukherjee
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients above 18 years of age with the ability to give consent. 2. Patients with histopathologically proven oral cavity carcinoma (SCC). 3. Patients with clinically N0 neck 4. Patients planned for surgical treatment including neck lymph node dissection as per standard guidelines.

Exclusion criteria

Exclusion criteria: 1. Clinically node-positive patients 2. Previous history of head & neck irradiation 3. Recurrent or distant metastatic oral cancer 4. Patients with inoperable oral cavity carcinoma 5. Patients not willing to be included in the study.

Design outcomes

Primary

MeasureTime frame
1. Identification of sentinel LN in the neck in patients with oral cavity squamous cell carcinoma with N0 neck using 1% methylene blue dye only, is technically feasible 2. Accurate identification of sentinel LN in the neck in patients with oral cavity squamous cell carcinoma with N0 neck using 1% methylene blue dye only, with more than 90% sensitivity and specificityTimepoint: Intraoperative and after pathological assessment

Secondary

MeasureTime frame
Accurate identification of sentinel LN in the neck for different subsite & stages in patients with oral cavity squamous cell carcinoma with N0 neck using 1% methylene blue dye only, with more than 90% sensitivity & specificityTimepoint: Intraoperative & after pathological assessment

Countries

India

Contacts

Public ContactDr Chiranjit Mukherjee

Himalayan Institute of Medical Science Swami Rama Himalayan University

sunilsaini@srhu.edu.in9412318966

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026