B-amyloid as a Marker for GBM Bioimaging

Status Not yet recruiting

Clinical Trial Summary

This project is aimed at improvement of glioblastoma (GBM) diagnostic strategies for discrimination of tumor progression and chemo- and radiotherapeutic treatment-related changes in brain tissue. The study will elucidate the diagnostic value of PET imaging with use of amyloid-β radioisotope tracer Amyvid (Florbetapir F18) for GBM. The results of the study will provide data for development of new approach for GBM diagnostics.

Clinical Trial Description

Glioblastoma (GBM) is one of the most malignant forms of brain cancer. Majority of GBMs relapse shortly after tumor resection, and the timely follow-up diagnosis and treatment is vital for patient's survival. However, chemo- and radiotherapeutic treatment of GBM patients cause metabolic and structural changes in brain parenchyma, manifested as metabolic and matrix remodeling modifications, and mimic tumor progression in magnetic resonance imaging (MRI) images. This creates difficulties in discrimination of real tumor progression and post-treatment modifications. No current imaging techniques, including MRI, magnetic resonance spectroscopy (MRS) or perfusion MR (MRP) can provide effective determination of tumor progression and treatment-related changes of brain tissue, that represents current unmet clinical need. The goal of the study is to identify specific biomarker for GBM, that can be used for precise imaging and diagnostics. The accumulation of amyloid-β in human GBM specimens and in mouse glioma implantation model was previously demonstrated. Intravenous administration of amyloid-β marker thioflavin T resulted in accumulation of fluorescence in brain tumors in mouse GBM model 15 minutes after administration and allowed detailed visualization of tumor structure with use of confocal microscopy. The hypothesis of the study is that Amyvid (Florbetapir F18), a radioisotope tracer, that binds amyloid aggregates and is currently used for brain PET diagnostics of Alzheimer disease, can be used as a safe and effective marker for PET diagnostics of recurrent GBM. The central study question: if Amyvid-PET provides visualization of GBM tumors and discriminate recurrent tumor and post-treatment tissue modifications in human brain, and thus presents the potential for amyloid-binding radioisotope tracers as GBM diagnostic tool. The purpose of the study is to characterize and describe the ability of Amyvid to reach GBM tumor in humans and to bind specific tumor structures as necrotic, middle and invasion areas of tumor, as well as blood vessel structures and extracellular matrix in tumor. The study is designed as human clinical trials phase 2A. ;

Study Design

Related Conditions & MeSH terms

Glioblastoma

Clinical Trial Details

NCT number	NCT05820191
Study type	Interventional
Source	Universidad Central del Caribe
Contact	Lilia Kucheryavykh, PhD
Phone	7877983001
Email	lilia.kucheryavykh@uccaribe.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	July 2024
Completion date	July 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05664243` - A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma	Phase 1/Phase 2
Completed	`NCT02768389` - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma	Early Phase 1
Recruiting	`NCT05635734` - Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma	Phase 1/Phase 2
Completed	`NCT03679754` - Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102	Phase 1
Completed	`NCT01250470` - Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma	Phase 1
Terminated	`NCT03927222` - Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma	Phase 2
Recruiting	`NCT03897491` - PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma	Phase 2
Active, not recruiting	`NCT03587038` - OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma	Phase 1
Completed	`NCT01922076` - Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas	Phase 1
Recruiting	`NCT04391062` - Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma	Phase 2
Active, not recruiting	`NCT03661723` - Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma	Phase 2
Active, not recruiting	`NCT02655601` - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001	Phase 2
Completed	`NCT02206230` - Trial of Hypofractionated Radiation Therapy for Glioblastoma	Phase 2
Completed	`NCT03493932` - Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade	Phase 1
Terminated	`NCT02709889` - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06058988` - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer	Phase 2
Completed	`NCT03018288` - Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)	Phase 2
Withdrawn	`NCT03980249` - Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells	Early Phase 1
Not yet recruiting	`NCT04552977` - A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma	Phase 2
Terminated	`NCT02905643` - Discerning Pseudoprogression vs True Tumor Growth in GBMs