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CTRI Number  CTRI/2025/06/089633 [Registered on: 26/06/2025] Trial Registered Prospectively
Last Modified On: 23/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing standard surveillance imaging to symptom based imaging in glioblastoma 
Scientific Title of Study   Surveillance versus symptom-directed magnetic resonance imaging in glioblastoma: Phase 3 randomized controlled trial (MAGNOLIA) 
Trial Acronym  MANGOLIA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arpita Sahu 
Designation  Professor, Radiodiagnosis 
Affiliation  Tata Memorial Centre Mumbai 
Address  Department of Radiodiagnosis Tata Memorial Hospital Parel Mumbai 400 012.

Mumbai
MAHARASHTRA
400012
India 
Phone  02269537300  
Fax    
Email  drarpitasahu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arpita Sahu 
Designation  Professor, Radiodiagnosis 
Affiliation  Tata Memorial Centre Mumbai 
Address  Department of Radiodiagnosis Tata Memorial Hospital Parel Mumbai 400 012.

Mumbai
MAHARASHTRA
400012
India 
Phone  02269537300  
Fax    
Email  drarpitasahu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arpita Sahu 
Designation  Professor, Radiodiagnosis 
Affiliation  Tata Memorial Centre Mumbai 
Address  Department of Radiodiagnosis Tata Memorial Hospital Parel Mumbai 400 012.

Mumbai
MAHARASHTRA
400012
India 
Phone  02269537300  
Fax    
Email  drarpitasahu@gmail.com  
 
Source of Monetary or Material Support  
Lady Tata Memorial Trust  
 
Primary Sponsor  
Name  Tata Memorial Centre 
Address  Dr E Borges Road, Mumbai 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arpita Sahu  Tata Memorial Centre  Dr E Borges Road, Mumbai
Mumbai
MAHARASHTRA 
7049000101

drarpitasahu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Surveillance  MRI will be done every 6 monthly 
Intervention  symptom based intervention  MRI will be done when patient is symptomatic 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age more than equal to 18years
Histopathological diagnosis of Glioblastoma.
Disease clinico radiologically controlled at the completion of standard therapy.
KPS more than or equal to 60
Signing informed consent
 
 
ExclusionCriteria 
Details  Patients without tissue diagnosis
IDH mutant gliomas
Patients with lesions indeterminate for recurrence
Pediatric patients less than 18 years.
Patients with confirmed recurrence.
Patients unable to be part of their own informed decision making due to cognitive impairment.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint of this study will be the 2 year overall survival
survival calculated from the date of diagnosis. 
3 years 
 
Secondary Outcome  
Outcome  TimePoints 
Progression free survival
Rates of salvage treatment
Quality of life
Cost effectiveness analysis 
3 years 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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 3 
Date of First Enrollment (India)   07/07/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Glioblastoma is the most common and aggressive malignant brain tumor in adults, with a median survival of approximately 15 months despite standard treatment, which includes maximal safe resection followed by chemoradiotherapy with temozolomide. Imaging, especially MRI, plays a key role in diagnosis, treatment planning, and surveillance; however, standardized imaging protocols for post-treatment follow-up remain undefined. Guidelines from major oncology bodies vary, with surveillance intervals ranging from 2 to 6 months. While routine imaging aims to detect early asymptomatic recurrences, emerging evidence questions its survival benefit and highlights concerns about cost, patient anxiety, and potential overtreatment due to misinterpretation of post-treatment changes.

The MAGNOLIA study is a randomized, open-label, Phase III trial comparing standard surveillance imaging to symptom-based imaging for glioblastoma patients post-treatment. Patients will undergo 3-monthly clinical evaluations, with either 6-monthly MRIs (standard arm) or imaging only upon symptom onset (experimental arm). The primary endpoint is 2-year overall survival, with secondary endpoints including progression-free survival, salvage treatment rates, quality of life, and cost-effectiveness.

A total of 240 adult patients with controlled glioblastoma post-standard therapy will be enrolled over 2 years and followed for one additional year. Statistical analysis will use Kaplan-Meier and log-rank tests, with quality of life assessed via EORTC QLQ-C30 and BN20 questionnaires. Ethical oversight, informed consent, and patient confidentiality are prioritized throughout. The study aims to provide evidence-based guidance on imaging strategies, potentially optimizing patient care while reducing unnecessary imaging and associated burdens.

 
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