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Methylene blue dye in the evaluation of the primary draining lymph nodes in localised, node-negative oral cavity cancer: a prospective study from a tertiary cancer center.

Single tracer methylene blue in the evaluation of sentinel nodes in squamous cell carcinoma of the buccal mucosa: a prospective study from a tertiary cancer center.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039523
Enrollment
40
Registered
2022-01-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: C060- Malignant neoplasm of cheek mucosa

Interventions

Intervention1: Peritumoral injection of methylene blue dye to identify the sentinel nodes.: After skin incision and raising of skin flaps as in a conventional neck dissection, dye will be injected per

Sponsors

Kidwai Memorial Institute of Oncology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Consecutive patients with biopsy proven, upfront operable SCC of the buccal mucosa, with no clinical or radiological evidence of cervical lymphadenopathy.

Exclusion criteria

Exclusion criteria: Patients who were under 18 years of age, oral cavity subsites other than buccal mucosa, with prior history of head and neck surgery, recurrent oral cancer or any form of neoadjuvant therapy, patients with palpable lymphadenopathy and those who did not consent to the procedure

Design outcomes

Primary

MeasureTime frame
Pattern of lymph nodal spread in buccal mucosa SCC SLN identification rate with blue dye The accuracy (including the true positive and false negative rate) of blue dye in predicting the nodal status of the neck.Timepoint: 8 weeks (at study completion)

Secondary

MeasureTime frame
Incidence of nodal metastases in clinically node negative SCC of the buccal mucosa Identification and correlation of tumor factors predictive of nodal involvement.Timepoint: 4 weeks

Countries

India

Contacts

Public ContactJoseph Mathew

Kidwai Memorial Institute of Oncology

drjosephmathew89@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026