| CTRI Number |
CTRI/2024/11/077180 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Fluorescein dye in patients with brain tumor surgery. |
|
Scientific Title of Study
|
Role of Intraoperative Fluorescein Sodium in resection of Intracranial High-Grade Gliomas. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAHUL SAIKIA |
| Designation |
DrNB Neurosurgery Resident, Institute of Neurosciences, Kolkata |
| Affiliation |
Institute of Neurosciences, Kolkata |
| Address |
Department of Neurosurgery, Institute of Neurosciences Kolkata. 185, Acharya Jagdish Chandra Bose Road, Elgin, Kolkata, West Bengal, India.
Kolkata
WEST BENGAL
700014
India |
| Phone |
8638782018 |
| Fax |
|
| Email |
rahuldbrt1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DEBARSHI CHATTERJEE |
| Designation |
Consultant Neurosurgeon, Institute of Neurosciences, Kolkata |
| Affiliation |
Institute of Neurosciences, Kolkata |
| Address |
Department of Neurosurgery Institute of Neurosciences Kolkata. 185, Acharya Jagdish Chandra Bose Road, Elgin, Kolkata, West Bengal, India.
Kolkata
WEST BENGAL
700017
India |
| Phone |
8872741184 |
| Fax |
|
| Email |
dc_chatto@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DEBARSHI CHATTERJEE |
| Designation |
Consultant Neurosurgeon, Institute of Neurosciences, Kolkata |
| Affiliation |
Institute of Neurosciences, Kolkata |
| Address |
Department of Neurosurgery Institute of Neurosciences Kolkata. 185, Acharya Jagdish Chandra Bose Road, Elgin, Kolkata, West Bengal, India.
Kolkata
WEST BENGAL
700017
India |
| Phone |
8872741184 |
| Fax |
|
| Email |
dc_chatto@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Neurosciences, Kolkata.
185, Acharya Jagdish Chandra Bose Road, Elgin, Kolkata, West Bengal, India. PIN-700017. |
|
|
Primary Sponsor
|
| Name |
RAHUL SAIKIA |
| Address |
Flat No.4D, 4th Floor, Shivam Towers, 22B Gorachand Road, Beniapukur, Kolkata, West Bengal. PIN-700014 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DEBARSHI CHATTERJEE |
Institute of Neurosciences, Kolkata |
Department of Neurosurgery.
185, Acharya Jagdish Chandra Bose Road, Elgin, Kolkata, West Bengal, India. PIN-700017.
Kolkata
WEST BENGAL |
8872741184
dc_chatto@hotmail.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: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients whose imaging shows features of high-grade gliomas.
2. Patients with high-grade gliomas where complete resection is planned pre-operatively.
|
|
| ExclusionCriteria |
| Details |
1. Patients with high-grade gliomas where complete resection is not planned (e.g. tumors in the eloquent areas, brainstem, thalamus, basal ganglia).
2. Patients who are unfit for surgery.
3. Histological diagnosis other than glioma.
4. Patients not willing to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is the residual tumor volume following resection in the fluorescein and non-fluorescein group. |
Post-operative contrast MRI will be done within 48 hours of resection to check for residual tumor volume. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome of the study is the quality of life of the patients following surgery. |
Patients will be followed up for a period of 3 months. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/12/2024 |
| 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="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
|
Gliomas are primary brain tumors of the central nervous system. Glioblastomas are the most common and aggressive type of gliomas associated with very poor prognosis. A strong correlation exists between the extent of removal of glioblastomas and the overall survival. Similarity of the tumor tissue with the surrounding brain parenchyma makes complete resection quite challenging. Fluorescein sodium may serve as a promising aid in intraoperative identification of tumor tissue and hence increasing the chances of complete resection. This study is conducted to see the results of fluorescein sodium in guiding the extent of tumor removal. This is a prospective observational study where patients fulfilling the study criteria will be included. In all cases, pre-operative MRI will be done within 7 days before surgery. The patients will be divided into two groups- a) Fluorescein group (FG) and b) Non-Fluorescein group(NFG). The patients who give consent for the use of fluorescein dye will be included in the fluorescein group, whereas the patients who don’t give consent for the use of this dye will be included in the non-fluorescein group. In FG the stained margins under Yellow 560 filter of the operating microscope will act as a guide in resection of the tumor, whereas patients in the NFG will undergo resection under the conventional white light microscope. Any adverse effects of the fluorescein dye will be recorded. Post-operative scans (MRI with contrast) will be done within 48 hours to see the extent of resection and check for residual tumor volume. Patients will be followed up for a period of 3 months (4 weeks and 3 months) to assess the quality of life. •Residual tumor volumes will be only defined as lesions having a maximum diameter and a vertical measurement of >1 cm. •Any adverse effects as a result of dye injection will be recorded. •Post-operatively patients will be followed up for a period of 3 months (4 weeks and 3 months) to check for any disease recurrence.
|