| 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
|
|
|
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
|
|
|
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. |