NCT05820191

B-amyloid as a Marker for GBM Bioimaging

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Universidad Central del Caribe · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Amyvid, Intravenous Solution	Amyvid 370MBq (10mCi) absorbed dose 7mSv of will be introduced intravenously and 30-50 minutes after the PET images will be acquired.

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-04-19
• Last updated: 2023-12-21

Locations

2 sites across 1 country: Puerto Rico

Regulatory

• FDA-regulated drug study