| 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
|
|
|
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
|
|
|
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. |