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CTRI Number  CTRI/2024/06/069485 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 14/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Diagnostic 
Study Design  Single Arm Study 
Public Title of Study   PSMA imaging and therapy in recurrent Glioblastoma Multiforme 
Scientific Title of Study   A pilot study to assess the status of PSMA as a theranostic target in recurrent glioblastoma multiforme 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nishikant Avinash Damle 
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Number 4, Department of Nuclear Medicine, Old RAK OPD, All India Institute of Medical Sciences, New Delhi.

South
DELHI
110029
India 
Phone  95960194828  
Fax    
Email  nkantdamle@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vishnu A R 
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Number 59A, Department of Nuclear Medicine, Old RAK OPD, All India Institute of Medical Sciences, New Delhi.

South
DELHI
110029
India 
Phone  95960194828  
Fax    
Email  vishnu.tprb23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vishnu A R 
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Number 4, Department of Nuclear Medicine, Old RAK OPD, All India Institute of Medical Sciences, New Delhi.

South
DELHI
110029
India 
Phone  95960194828  
Fax    
Email  vishnu.tprb23@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 
 
Primary Sponsor  
Name  Nil 
Address  Not Applicable 
Type of Sponsor  Other [Nil] 
 
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 Nishikant Damle  All India Institute of Medical Sciences  Nuclear Medicine department, Old RAK OPD, AIIMS, Ansari Nagar, Delhi
South
DELHI 
9560194828

nkantdamle@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMIMITEE FOR POST GRADUATE RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ga68 PSMA 11 PET CT  5 mCi Ga68 PSMA scan for diagnostic purpose will be injected intravenously and scan will be acquired after 45 mins to 1 hour 
Intervention  PSMA dosimetry and therapy  5 mCi Lu 177 PSMA 617 for dosimetry and 100 to 200 mCi for therapy will be injected intravenously FOr dosimetry scans will be acquired at 1 hour ( prevoid), 4 hours, 24 hours, 48 hours and more than 72 hours after injection For therapy 100 to 200mCi will be injected intravenously every 2 months upto 4 cycles. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Aged 18 years or above and providing written informed consent. • Histological confirmation of the glioblastoma. • Advanced stage disease with PSMA avid recurrence on 68Ga-PSMA11 PET/CT scan.
Progressive disease after standard-of-care treatments
Life expectancy greater than 12 weeks
Patients willing to undergo serial whole-body scans and provide blood and urine samples for dosimetry analysis 
 
ExclusionCriteria 
Details  Eastern Cooperative Oncology Group (ECOG) performance status more than 4.
Uncontrolled intercurrent illness
Pregnant and/or lactating women.
Refusal to give written informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the PSMA expression in recurrent glioblastoma multiforme using 68Ga-PSMA 11 PET CT  0 to 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the biodistribution and tumor retention of PSMA-based therapeutic radiopharmaceutical
(177Lu PSMA 617) 
6-18 months 
To administer the 177Lu PSMA 617 at therapeutic doses and evaluate the safety and efficacy of the
therapy in the study population by assessing the toxicity profile and quality of life (QOL), progression-free survival (PFS) and Overall Survival (OS) after treatment. 
12 - 24 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   08/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  08/07/2024 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 multiforme (GBM), a tumor derived from glial cells, is the most common primary brain tumor in adults accounting for 45.2% of malignant primary brain and CNS tumors. Primary GBMs account for 80% of GBMs and mostly occur in older patients with a mean age of 62 years while secondary GBMs occur from lowergrade astrocytoma or oligodendroglioma mostly in younger patients with a mean age of 45 years. GBM is a highly vascularized tumor. The World Health Organization in their 2021 classification defines GBM as a grade IV cancer characterized as malignant, mitotically active, and predisposed to necrosis associated with a very poor prognosis with a mean age of survival of approximately six months that can be very difficult to cure, and the current treatment options have no optimal outcomes. As the treatment options in recurrent high-grade gliomas are limited, new therapeutic perspectives with the use of radiolabeled agents are studied.
Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein, expressed predominantly in prostate cancer (PCa) cells. It is encoded by the FOLH1 gene located on the short arm of the chromosome. It has neuropeptidase and folate hydrolase activity and plays a role in cell survival, cell migration, and nutrient uptake. The internalization process of the PSMA receptor allows for the bound molecules to reach significant concentration within the cell and this process can be imaged using a radioactive tracer tagged with Gallium 68. Apart from expression in PCa cells, it was found to have PSMA expression in the neovasculature of triplenegative breast cancer, lung cancer, pancreatic cancers, and certain other malignancies.
177Lutetium (177Lu), with a half-life of 6.73 days when combined with PSMA ligands (such as PSMA 617) can be used for the destruction of tumor cells due to its medium‐energy β‐emission (497 keV) and a mean tissue penetration of 670 μm. It also emits low‐energy γ‐rays at 208 and 113 keV with 10 and 6% abundance respectively which allows for its imaging via gamma camera.
There is proven efficacy of 177Lutetium (177Lu) therapy in Prostate cancer (mCRPC) (10) and a couple of studies have tried to study the efficacy in GBM with encouraging results. Hence, the purpose of this study is to determine the status of PSMA as a theranostic target using 68Ga PSMA-11 and 177Lu-PSMA-617 in GBM patient.
 
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