| CTRI Number |
CTRI/2024/05/067253 [Registered on: 13/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Descriptive Feasibility study] |
| Study Design |
Other |
|
Public Title of Study
|
Mapping lymphatic drainage patterns in recurrent oral cavity squamous cell carcinoma using sentinel lymph node biopsy. |
|
Scientific Title of Study
|
Utilizing sentinel lymph node biopsy to identify the lymphatic drainage pattern in clinically node negative recurrent oral cavity squamous cell
carcinoma. A feasibility 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 |
Dr Vidisha Tuljapurkar |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1224, 12th floor, Homi Bhabha Building, Tata Memorial Hospital, Dr E Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177000 |
| Fax |
|
| Email |
vidishavt@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Latika Kansal |
| Designation |
Resident |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 296, 2nd floor, Homi Bhabha Building, Tata Memorial Hospital, Dr E Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177000 |
| Fax |
|
| Email |
latikakansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidisha Tuljapurkar |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room No 1224, 12th floor, Homi Bhabha Building, Tata Memorial Hospital, Dr E Borges Road, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
24177000 |
| Fax |
|
| Email |
vidishavt@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital
Dr E borges Road Parel Mumbai 400012 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| DrVidisha Tuljapurkar |
Tata Memorial Hospital |
Room No 1224, 12th floor, Homi Bhabha Building, Tata Memorial Hospital, Dr E Borges Road, Parel
Mumbai
MAHARASHTRA |
02224177187
vidishavt@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Technetium 99 nanocolloid |
Dose- 0.2ml
Route - peritumoral
Frequency - once
Duration - 30min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Biopsy proven recurrent or second primary invasive squamous cell carcinoma of oral
cavity on the side which has previously been treated with neck dissection or
radiation
2 Clinicoradiologically T1, T2, T3 tumors with node negative disease and no distant
metastases on whole body PET CECT
3 Planned for curative intent surgical excision of the primary tumor with elective neck dissection of the contralateral side |
|
| ExclusionCriteria |
| Details |
1 Patients with reduced mouth opening where peritumoral injection of radiotracer along 4 quadrants not possible
2 Patients who are not suitable for curative intent surgery or neck dissection for medical or surgical reasons
3 Patients in whom bilateral neck dissection has been done in the previous surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify the patterns of lymphatic drainage patterns in patients
with recurrent OSCC with previously treated neck |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the accuracy of PET CECT and SLNB for detection of LN metastases in recurrent OSCC as compared to the final histopathology report |
1 Month |
| To assess the sensitivity, specificity, positive and negative predictive value of SLNB |
1 Month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/05/2024 |
| 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="4"
Months="0"
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
|
Sentinel Lymph Node Biopsy (SLNB) has been proven to be an accurate predictor of lymphatic drainage in treatment of naïve oral cavity SCC with a sensitivity of 94%. However, necks that have been previously treated by either surgery or radiotherapy may have an alteration of lymphatic channels and therefore, erratic drainage patterns. Clinical and radiological examination of such necks may not yield an accurate prediction as occult metastasis is difficult to gauge via these modalities. Appropriate clinical and pathological staging of these necks is of the essence in the management of recurrent oral cavity SCCs. |