| CTRI Number |
CTRI/2025/11/097482 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
15/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Validation Study |
| Study Design |
Other |
|
Public Title of Study
|
Using Sentinel Lymph Node Biopsy to Detect Hidden Cancer Spread to the Opposite Side of the Neck in Midline Oral Cancer: A Prospective Study |
|
Scientific Title of Study
|
The Role of Sentinel Lymph Node Biopsy In Detecting Occult Contralateral Neck Nodal Metastasis in Midline Approaching Oral Squamous Cell Carcinoma- A Prospective Validation Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akash Kumar Ray |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences- Jodhpur |
| Address |
Basni Industrial area Phase 2
Department of Surgical Oncology,
Room no 509
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9073204910 |
| Fax |
|
| Email |
aroy1393@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeewan Ram Vishnoi |
| Designation |
Additional Professor and Head of the Department |
| Affiliation |
All India Institute Of Medical Sciences- Jodhpur |
| Address |
Basni Industrial area Phase 2
Department of Surgical Oncology, Room no 509
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9455061569 |
| Fax |
|
| Email |
drjvishnoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akash Kumar Ray |
| Designation |
Senior Resident |
| Affiliation |
All India Institute Of Medical Sciences- Jodhpur |
| Address |
Basni Industrial area Phase 2
Department of Surgical Oncology, Room no 509
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9073204910 |
| Fax |
|
| Email |
aroy1393@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
AIIMS, Basni, Industrial area phase 2,Jodhpur, Rajasthan, 342005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akash Kumar Ray |
AIIMS JODHPUR |
Bansi, Industrial Area Phase 2
Department of Surgical Oncology, Room no 509
Jodhpur
RAJASTHAN |
09073204910
aroy1393@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Histologically proven Oral SCC approaching or crossing midline or with bulky ipsilateral nodal disease, in patients aged 18- 70 years and clinically or radiologically proven contralateral N0 undergoing surgery with curative intention. |
|
| ExclusionCriteria |
| Details |
Synchronous tumours in Head and Neck region
Previous history of neck dissection or irradiation
Burns over neck and face
Clinically/Radiologically Contralateral N+
Recurrent disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity of SLNB in detecting contralateral neck nodal metastasis |
Intraoperatively and with final histopathological report |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Identification Rate (IR) of contralateral LN metastasis
-Specificity & false negative rate of SLNB for contralateral LN metastasis
-Mapping of contralateral lymphatic drainage |
Intraoperatively & with final histopathological report |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Population:
18 to 70 years Intervention:
Peritumoral injection of a radiotracer or dye will be performed, followed by lymphoscintigraphy and intraoperative sentinel lymph node biopsy (SLNB) using advanced imaging and a gamma probe to detect sentinel lymph nodes, particularly in the contralateral neck. Comparison: N/A Outcome:
The primary outcome is the sensitivity of SLNB in detecting contralateral lymph node metastasis in OSCC cases approaching or crossing the midline. Secondary outcomes include the identification rate of contralateral lymph node metastasis, specificity, false negative rates, and mapping patterns of contralateral lymphatic drainage. Time: N/A (single point assessment during surgery) Research Question:
Can contralateral neck dissection be avoided with the help of SLNB in lesions approaching midline? This study aims to assess the effectiveness of SLNB and lymphatic mapping in identifying contralateral cervical lymph node metastasis in midline approaching OSCC (MOSCC) with sensitivity as the primary and identification rate, specificity, false negative rate, and lymphatic drainage patterns of the contralateral neck as secondary objectives Inclusion Criteria: Histologically proven OSCC approaching midline In ages 18-70 years with contralateral negative neck with curative intent surgery Exclusion Criteria: Synchronous/recurrent head and neck tumors, previously irradiated/ surgically explored neck and proven contralateral nodal disease
|