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Detection of first draining lymph node in oral squamous cell carcinoma with no lymphatic spread at neck by comparing sulphur colloid and nanoparticle

Sentinel lymph node detection in oral squamous cell carcinoma with negative neck: comparison between [99mTc] Sulphur colloid and [99mTc] DTPA anti-Cytokeratin Collagenous Nanoparticle (DC-Col NP) - nil

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064206
Enrollment
30
Registered
2024-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: Peritumoral injection of collagenous nanoparticle: One time injection of collagenous nanoparticle with dose 0.5 ml (1-2 mCi) at route peritumoral in selected cases of oral cavity squamo

Sponsors

Department of Otorhinolaryngology, Head and Neck surgery AIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients above 18 years of age 2. Histologically proven squamous cell carcinoma of oral cavity 3. T1-T4 as per 8th AJCC 4. Clinically and radiologically N0 status in the neck 5. Patients giving consent for surgical modality of treatment.

Exclusion criteria

Exclusion criteria: 1. Patients who are poor candidates for general anesthesia 2. Presence of neck metastasis or distant metastasis 3. Patients with a history of recurrent head and neck malignancies. 4. Previous surgery or radiotherapy to head and neck

Design outcomes

Primary

MeasureTime frame
1.Sensitivity of sentinel lymph node mapping by use of Sulphur colloid and lymphoscintigraphy & SPECT imaging will be compared with selective neck dissection as gold standard. 2.Sensitivity of sentinel lymph node mapping by use of DC-Col NP and lymphoscintigraphy & SPECT imaging will be compared with selective neck dissection as gold standard. 3.will calculate Negative predictive value 4.will assess Kinetics flow along the lymphatic pathways Timepoint: 8 weeks

Secondary

MeasureTime frame
1. The diagnostic accuracy of both the techniques will be compared with each other. 2. Toxicity in both groups will be evaluated & compared. Timepoint: 8 weeks

Countries

India

Contacts

Public ContactNongthombam Surjalata Devi

AIIMS DELHI

drathakar@gmail.com9999755916

Outcome results

None listed

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