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CTRI Number  CTRI/2024/04/066374 [Registered on: 26/04/2024] Trial Registered Prospectively
Last Modified On: 26/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to see if a new way of looking at meningiomas (a type of brain tumor) using a special kind of scan called 68Ga-DOTATATE PET/CT is as good as the usual MRI scan we use 
Scientific Title of Study   A prospective pilot study to compare target volume delineation in meningiomas using 68Ga-DOTATATE PET/CT (positron emission tomography/ computed tomography) and current standard of care imaging (MRI) 
Trial Acronym  DOMMRAD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Fraser Borgio 
Designation  Junior Resident 
Affiliation  Christian Medical College, Vellore 
Address  Room number M1, Department of Radiation Oncology, Unit III, Christian Medical College, Dr. Ida Scudder Road, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  7639525653  
Fax    
Email  fraserborgio95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rajesh Balakrishnan 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Room number M1, Department of Radiation Oncology, Unit III, Christian Medical College, Dr. Ida Scudder Road, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9442169744  
Fax    
Email  drrajeshb77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajesh Balakrishnan 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Room number M1, Department of Radiation Oncology, Unit III, Christian Medical College, Dr. Ida Scudder Road, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9442169744  
Fax    
Email  drrajeshb77@gmail.com  
 
Source of Monetary or Material Support  
Christian Medical College, Vellore, Tamil Nadu, India- 632004 
 
Primary Sponsor  
Name  Christian Medical College, Vellore 
Address  Dr. Ida Scudder Road,Vellore,Tamil Nadu-632004  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh
India
Ethiopia  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Fraser Borgio  Christian Medical College and Hospital  Room number M1 Department of Radiation Oncology, Unit III
Vellore
TAMIL NADU 
7639525653

fraserborgio95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD, CHRISTIAN MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D320||Benign neoplasm of cerebral meninges,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Any meningioma with at least 10 mm measurable residual disease.
2. Meningioma patients planned for radiation therapy.
3. Ability to understand and the willingness to sign an IRB approved written informed consent document in accordance with regulatory and institutional guidelines before study entry.
4. For woman of childbearing potential who are intermediate or high risk, must be negative for pregnancy at time of beginning of radiation and should be willing to practice adequate contraception throughout the entire course of EBRT.
5. Resected WHO Grade 1 or 2 meningiomas with inadequate margins.
4. WHO Grade 3 meningiomas
5. Unresectable symptomatic meningiomas 
 
ExclusionCriteria 
Details  1. Neurofibromatosis Type 1,2
2. Extracranial meningioma
3. Previous radiation therapy given to the scalp, cranium, brain, or skull base within the last 3 years
4. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years.
5. Pregnancy
6. Inability to receive gadolinium, for e.g. allergy
7. Inability to undergo Ga 68- DOTAPET, for e.g. non co-operative.
8. Resected WHO Grade 1 or 2 meningiomas with adequate margins.
9. Asymptomatic unresectable meningiomas. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Differences in Gross tumor volume delineation of meningiomas by using 68Ga-DOTATATE PET/CT and gadolinium-enhanced standard MRI in comparison with each other.  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
Differences in planning target volume (PTV) contoured using 68Ga-DOTATATE PET/CT versus standard gadolinium enhanced MRI.   2 years 
Comparing OAR (Organs at risk) doses between treatment volumes contoured using 68Ga- DOTATATE PET/CT with those contoured using MRI with gadolinium  2 years 
Assessing the patterns of recurrence of meningiomas in patients who have received radiation  2 years 
 
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)   10/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/05/2024 
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)   Open to Recruitment 
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  
Intracranial meningioma is one of the most common primary intracranial tumors. It constitutes 10%–15% of all brain neoplasm across the globe, whereas in India, their occurrence varies from 11.6% to 21%. The mainstay of therapy is surgical resection. Adjuvant radiation therapy can be offered for high grade, unresectable, incompletely resected, or recurrent disease. The usage of advanced techniques such as stereotactic radiosurgery and intensity modulated radiation therapy ensures a highly conformal dose to tumour and reduces the dose to surrounding healthy tissues at the same time. The efficacy of these techniques is dependent on accurate target delineation, currently defined by computed tomography (CT) and magnetic resonance imaging (MRI) with gadolinium, the standard for defining disease extent. 

However, in infiltrative lesions and in the case of scar formation after surgery or radiation, studies have shown that contrast enhanced MRI imaging may be limited in terms of sensitivity and specificity of diagnosis due to, for example, unspecific contrast enhancement of scar tissue. 

Majority of the meningiomas are known to express somatostatin receptor-2 (SSTR2), and with an excellent tumour-to-background ratio, imaging with somatostatin receptor ligands has been established as a method for detection and target volume definition of meningiomas before radiation therapy. 

The somatostatin analog DOTATATE has shown high affinity for SSTR2. Labeled with the positron-emitting generator nuclide 68Ga, DOTATATE is increasingly being used for PET investigation of meningiomas, particularly for treatment planning. 

This study aims to demonstrate the advantages and disadvantages of incorporating 68Ga- DOTATATE PET/CT for target volume delineation in meningiomas planned for radiation therapy. 
 
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