Utility of FAPI as a potential diagnostic and therapeutic agent in recurrent glioblastoma multiforme patients

A pilot study to assess the status of 177Lu-FAPI as a potential theranostic agent in recurrent glioblastoma multiforme patients - NIL

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097005

Enrollment

Registered

2025-11-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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: 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 wi

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: Eastern Cooperative Oncology Group performance status more than 3. Pregnant or lactating women. Refusal to give written informed consent. Uncontrolled intercurrent illness.

Design outcomes

Primary

Measure	Time frame
To assess FAP expression in-vivo in recurrent glioblastoma multiforme patients using 68Ga-FAPI (46/2286) PET/CT.Timepoint: 0-12 months	—

Secondary

Measure	Time frame
(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. Timepoint: 12-24 months	—

Countries

India

Contacts

Public ContactDr Komal Bishnoi

All India Institute of Medical Sciences, New Delhi

komal.dehru80757@gmail.com7988934811

Outcome results

None listed

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