B-amyloid as a Marker for GBM Bioimaging

Trial Title: B-amyloid as a Marker for GBM Bioimaging

NCT ID: NCT05820191

Condition: Glioblastoma

Conditions: Official terms:
Glioblastoma

Conditions: Keywords:
Glioblastoma, Amyvid

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: 3 patients, diagnosed with GBM, who underwent tumor resection surgery with concurrent chemo- and/or radiotherapy and developed enlarging tumor lesion, will be involved to the study. PET-CT with use of Amyvid radioisotope tracer will be performed for 3 study participants. Amyvid-PET images will be analyzed together with previously performed MRI, MRS and MRP images, to identify pattern of deposition in tumor and peri-tumoral areas of brain.Tissue specimens, separated from total tumor after planned surgical resection and prior Amyvid-PET analysis, will be analyzed to identify amyloid-β expression level, tumor phenotype and vascularization. Data will be correlated with PET images to determine whether Amyvid-positive patterns represent distinct tumor phenotype.

Primary purpose: Diagnostic

Masking: None (Open Label)

Masking description: Double blinding analysis of PET images will be performed. Involved Radiologists will provide their independent opinions. In addition, blinding research strategy with withholding of patient information, with three independent people involved for data collection and analysis will be used.

Intervention:

Intervention type: Drug
Intervention name: Amyvid, Intravenous Solution
Description: Amyvid 370MBq (10mCi) absorbed dose 7mSv of will be introduced intravenously and 30-50 minutes after the PET images will be acquired.
Arm group label: AMY-GBM

Other name: Florbetapir-f18

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - GBM diagnose confirmed by MRI and histopathology - Had undergone gross total or subtotal resection of their tumor and developed enlarging and/or new enhancing lesion(s), recommended for second resection - Had or had not received radiation therapy with concomitant and adjuvant TMZ chemotherapy - Had pre-operative and follow up conventional MRI, MRS and/or Perfusion MR scans, available for analysis Exclusion Criteria: • Previous allergic reaction to radioisotope tracers

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Central University of the Caribbean (UCC)

Address:
City: Bayamon
Zip: 00956
Country: Puerto Rico

Contact:
Last name: Lilia Kucheryavykh, PhD

Phone: 7877983001

Phone ext: 2037
Email: lilia.kucheryavykh@uccaribe.edu

Investigator:
Last name: Lilia Kucheryavykh, PhD
Email: Principal Investigator

Facility:
Name: University of Puerto Rico, Medical Science Campus

Address:
City: San Juan
Zip: 0921
Country: Puerto Rico

Contact:
Last name: Miguel Mayol Del Valle, MD

Phone: 787-758-2525
Email: miguel.mayol@upr.edu

Investigator:
Last name: Miguel Mayol Del Valle, MD
Email: Sub-Investigator

Start date: July 2024

Completion date: July 2026

Lead sponsor:
Agency: Universidad Central del Caribe
Agency class: Other

Collaborator:
Agency: University of Puerto Rico
Agency class: Other

Source: Universidad Central del Caribe

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05820191