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CTRI Number  CTRI/2025/11/097005 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [FAPI (68Ga and 177Lu)]  
Study Design  Single Arm Study 
Public Title of Study   Utility of FAPI as a potential diagnostic and therapeutic agent in recurrent glioblastoma multiforme patients 
Scientific Title of Study   A pilot study to assess the status of 177Lu-FAPI as a potential theranostic agent in recurrent glioblastoma multiforme patients 
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  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

New Delhi
DELHI
110029
India 
Phone  9560194828  
Fax    
Email  nkantdamle@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Komal Bishnoi 
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

New Delhi
DELHI
110029
India 
Phone  7988934811  
Fax    
Email  komal.dehru80757@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Komal Bishnoi 
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

New Delhi
DELHI
110029
India 
Phone  7988934811  
Fax    
Email  komal.dehru80757@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi, India 
 
Primary Sponsor  
Name  Not Applicable 
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 Avinash Damle  All India Institute of Medical Sciences, New Delhi  Room 59-A, Department of Nuclear Medicine, All India Institute of Medical Sciences
New Delhi
DELHI 
9560194828

nkantdamle@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, ALL INDIA INSITUTE OF MEDICAL SCIENCES  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 
Intervention  FAPI (68Ga and 177Lu)  68Ga-FAPI (46/2286) will be injected intravenously at a fixed dose of approximately 3-5 mCi. The fixed dosage for low-dose 177Lu-FAPI (46/2286) dosimetry scans will be ~5-7 mCi and scan scans will be acquired at 2 hours, 24 hours, 96 hours and 7 days after injection. 177Lu-FAPI (46/2286) therapy will be injected intravenously at a dose of approximately 30-200 mCi/cycle according to tumor burden, patient weight and renal function. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age 18 years or above and providing written consent. Histological confirmation of glioblastoma. Advanced-stage disease with FAPI avid recurrence on 68Ga-FAPI PET/CT scan. Progressive disease after standard-of-care treatment. Life expectancy greater than 12 weeks. For 177Lu-FAPI-46 therapy, adequate end organ function 4 weeks before study, as given by
Hemoglobin more than or equal to 10g/dl.
Leucocytes more than or equal to 3000/mcL. Platelets more than or equal to 75,000/mcL. Total Bilirubin less than or equal to 3 x upper limit. AST/ALT/ALP less than or equal to 3 x upper limit. S. Creatinine less than or equal 1.7 mg/dl.
 
 
ExclusionCriteria 
Details  Eastern Cooperative Oncology Group performance status more than 3. Pregnant or lactating women. Refusal to give written informed consent. Uncontrolled intercurrent illness.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess FAP expression in-vivo in recurrent glioblastoma multiforme patients using 68Ga-FAPI (46/2286) PET/CT.  0-12 months 
 
Secondary Outcome  
Outcome  TimePoints 
(1) To assess the biodistribution and tumor retention of FAPI based therapeutic radiopharmaceutical (177Lu-FAPI 46/2286). (2) To assess the safety and efficacy of 177Lu-FAPI (46/2286) therapy in study population using clinical parameters, PERCIST, MRI brain and Overall Survival (OS) after treatment.
 
12-24 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 1/ Phase 2 
Date of First Enrollment (India)   21/11/2025 
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="2"
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 is the most common and aggressive primary malignant brain tumor in adults accounting for about 45 percent of cases. It is classified as a World Health Organization grade IV tumor characterized by endothelial proliferation and necrosis with a poor prognosis. The median overall survival is 12 to 15 months and the five year survival rate is only 4 to 5 percent. Standard management includes magnetic resonance imaging based diagnosis followed by maximal safe surgical resection and concurrent chemoradiation with temozolomide. Prognosis depends on factors such as age performance status and MGMT promoter methylation which predicts better response to temozolomide.

Despite aggressive treatment recurrence occurs in 80 to 90 percent of cases near the resection site and few advances have been made since bevacizumab approval in 2009. Recent research has focused on novel theranostic approaches targeting fibroblast activation protein FAP which is highly expressed in the tumor microenvironment of GBM but minimally in normal tissues.

Lutetium 177 labeled FAP inhibitors Lu 177 FAPI offer a promising strategy by combining diagnostic imaging and targeted beta therapy. Lutetium 177 emits medium energy beta particles with limited tissue range and low energy gamma photons suitable for imaging. Although studies on Lu 177 FAPI in GBM are limited early findings are encouraging and support further evaluation of this agent as a potential theranostic option in recurrent glioblastoma multiforme.

 
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