| 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
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Dr E Borges Road, Mumbai |
| 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 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
|
|
|
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.
|