Clinical Trials Logo

Clinical Trial Summary

This interventional, clinical pilot-study will initiate and evaluate 68Ga/177Lu-PSMA theranostics in Norway as treatment alternative for patients with recurrent grade 3 and grade 4 gliomas. The main goal is to improve existing diagnostic and therapeutic methods in glioma management, and introduce a novel, well-tolerated radionuclide treatment that possibly can increase the overall survival and quality of life for a patient group that today have very short expected survival and no standard recommended therapy.


Clinical Trial Description

Patients demonstrating a high tumor uptake of 68Ga-PSMA on the diagnostic PET/MRI examination in the screening part of the study are eligible for a standard of 3 cycles, with a possible extension to maximum number of 6 cycles, of 177Lu-PSMA radionuclide therapy sessions. SPECT/CT will be performed after each cycle of treatment for dosimetry calculations, while 68Ga-PSMA PET/MRI, quality-of-life schemes and clinical examinations will be used to monitor therapeutic effects during the therapy cycles and up to 1.5 year after treatment initiation. The main endpoints of the study are progression-free survival and overall survival. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05644080
Study type Interventional
Source St. Olavs Hospital
Contact Tora Solheim, MD/PhD
Phone +4772826136
Email tora.solheim@ntnu.no
Status Recruiting
Phase N/A
Start date March 28, 2023
Completion date December 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05023551 - Study of DSP-0390 in Patients With Recurrent High-Grade Glioma Early Phase 1
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Active, not recruiting NCT02655601 - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001 Phase 2
Terminated NCT03690869 - REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma Phase 1/Phase 2
Completed NCT01466686 - Low Dose Radiation Therapy for Glioblastoma Multiforme Phase 2
Recruiting NCT05925218 - Circulating Tumor DNA Collection From Patients With High Grade Gliomas
Recruiting NCT05212272 - MRI in High-Grade Glioma Patients Undergoing Chemoradiation
Active, not recruiting NCT04911621 - Adjuvant Dendritic Cell Immunotherapy for Pediatric Patients With High-grade Glioma or Diffuse Intrinsic Pontine Glioma Phase 1/Phase 2
Not yet recruiting NCT06333899 - Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion Early Phase 1
Recruiting NCT04734444 - SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue N/A
Completed NCT03775369 - Glioma and Exercising N/A
Completed NCT02022644 - Study of Convection-Enhanced, Image-Assisted Delivery of Liposomal-Irinotecan In Recurrent High Grade Glioma Phase 1
Completed NCT00780819 - Borderzone Sampling N/A
Recruiting NCT06072586 - Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions Early Phase 1
Completed NCT01390948 - A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma Phase 2
Recruiting NCT03952598 - Studying the Biology of IDH-mutant Gliomas Via Longitudinal Observation of 2-hydroxyglutarate (2-HG) Using MR Spectroscopy N/A
Recruiting NCT05630664 - Liquid Biopsy in High-grade Gliomas and Meningiomas
Recruiting NCT05298995 - GD2-CAR T Cells for Pediatric Brain Tumours Phase 1
Completed NCT01222754 - Lenalidomide and Radiation Therapy in High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas Phase 1
Recruiting NCT05278208 - Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors Phase 1/Phase 2