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PSMA imaging and therapy in recurrent Glioblastoma Multiforme

A pilot study to assess the status of PSMA as a theranostic target in recurrent glioblastoma multiforme - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069485
Enrollment
30
Registered
2024-06-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C719- Malignant neoplasm of brain, unspecified

Interventions

Intervention1: 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),

Sponsors

Nil
Lead Sponsor

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

MeasureTime frame
To assess the PSMA expression in recurrent glioblastoma multiforme using 68Ga-PSMA 11 PET CTTimepoint: 0 to 6 months

Secondary

MeasureTime 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

Public ContactDr Vishnu A R

All India Institute of Medical Sciences, New Delhi

vishnu.tprb23@gmail.com95960194828

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026