| 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
|
|
|
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
|
|
|
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 mediumâ€energy βâ€emission (497 keV) and a mean tissue penetration of 670 μm. It also emits lowâ€energy γâ€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. |