Health Condition 1: C719- Malignant neoplasm of brain, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Eastern Cooperative Oncology Group (ECOG) performance status more than 4. Uncontrolled intercurrent illness Pregnant and/or lactating women. Refusal to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the PSMA expression in recurrent glioblastoma multiforme using 68Ga-PSMA 11 PET CTTimepoint: 0 to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 12 - 24 months;To assess the biodistribution and tumor retention of PSMA-based therapeutic radiopharmaceutical (177Lu PSMA 617)Timepoint: 6-18 months | — |
Countries
India
Contacts
All India Institute of Medical Sciences, New Delhi