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Sentinel node biopsy in oral cancer.

The role of sentinel node biopsy in early oral cavity cancer - A prospective validation study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021171
Enrollment
39
Registered
2019-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C029- Malignant neoplasm of tongue, unspecified

Interventions

Intervention1: SLNB - sentinal lymph node biopsy using the hand held gamma probe and SPECT CT: 99mTc-labelled radiotracer will be used in the study. A total injected activity of 70-120 MBq (1.9-3.24 m

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Early oral cancer (cT1 and T2) â?? biopsy proven 2. Patient planned for upfront surgery 3. Clinically N0 Neck 4. Willing to participate in the study

Exclusion criteria

Exclusion criteria: 1. Recurrent oral cavity cancer or second primary oral cavity tumour 2. Tumor within two centimetres of the midline 3. History of prior radiation to head and neck region 4. Allergy to the dye 5. Presence of major co-morbidities making the patient unfit for surgery 6. Any past history extensive surgery in the oral cavity or in neck which might have resulted in the disruption of lymphatics 7. Pregnant patients

Design outcomes

Primary

MeasureTime frame
To assess the feasibility of SLNB in the management of early oral cavity cancer using combined blue dye and radiotracer technique.Timepoint: september 2021—

Secondary

MeasureTime frame
To compare the Sensitivity, specificity, negative predictive value, positive predictive value and accuracy of SLNB in oral cancer using radioactive tracer and blue dye alone versus combined method Timepoint: 24 months; To compare the diagnostic accuracy of frozen section examination with paraffin section examination of sentinel nodes Timepoint: 24 months; To estimate the Sensitivity, specificity, negative predictive value, positive predictive value and accuracy of SLNB in oral cancer Timepoint: 24 months;To compare the lymphoscintigraphic detection with intraoperative detection of SLNB using gamma camera Timepoint: 24 months;To determine the identification rate of SLNB in early oral cavity cancer Timepoint: 24 months—

Countries

India

Contacts

Public ContactDr Pankaj Kumar Garg

AIIMS Rishikesh

dr.pankajgarg@gmail.com9868708542

Outcome results

None listed

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