| CTRI Number |
CTRI/2019/01/017325 [Registered on: 31/01/2019] Trial Registered Prospectively |
| Last Modified On: |
01/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of fluorescein in brain tumor surgery |
|
Scientific Title of Study
|
Fluorescein guided surgery for resection of malignant glioma: A randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Patil |
| Designation |
Senior Resident Neurosurgery |
| Affiliation |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh,
Virbhadra Marg,
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
adipatil01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajnish Kumar Arora |
| Designation |
Associate Proffesor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Neurosurgery, AIIMS Rishikesh,
Virbhadra Marg,
Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
rajnish_19@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya Patil |
| Designation |
Senior Resident Neurosurgery |
| Affiliation |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh,
Virbhadra Marg,
Rishikesh
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
adipatil01@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Neurosurgery |
| Address |
AIIMS Rishkiesh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Aditya Patil |
AIIMS Rishikesh |
Department of neurosurgery.
Dehradun
UTTARANCHAL |
9781815533
adipatil01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C71||Malignant neoplasm of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sodium Fluorescein |
Used as a dye intra-operatively to visualise the tumor tissue
Dose 5-8mg/kg
Given intravenously during surgical excision |
| Comparator Agent |
Standard surgical resection of glioma using microneurosurgical methods |
Standard surgical resection of glioma using microneurosurgical methods |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
72.00 Year(s) |
| Gender |
Both |
| Details |
newly diagnosed, untreated suspected high grade glioma and who are eligible for surgery according to the study surgeon |
|
| ExclusionCriteria |
| Details |
1. tumours of the midline, basal ganglia, cerebellum, or brain stem as assessed by MRI
2. more than one contrast-enhancing lesion
3. substantial, non-contrast enhancing tumour areas suggesting low-grade glioma
with malignant trans formation
4.medical reasons precluding MRI (eg, pacemaker, metallic implants)
5. inability to give consent because of dysphasia or language barrier
6.tumour location did not enable complete resection of
contrast-enhancing tumour as decided by individual
study surgeon;
7. Karnofsky performance scale 60 or less;
8. renal insufficiency
9.hepatic insufficiency
10.history of malignant tumours at any other body site
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with histologically confirmed malignant glioma on neuropathological review without residual contrast-enhancing tumour on postoperative MRI, and progression-free survival at 6 months |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Residual tumour volume on postoperative MRI
2.Overall survival
3.Type and severity of neurological deficits after surgery
4.Toxic effects
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
04/02/2019 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We aim to do a randomised controlled trial to
assess the use of fluorescence in
malignant glioma after administration of Sodium Fluorescein improving resection
as defined by postoperative MRI, and to analyse the effect of resection on progression
free survival and neurological morbidity |