B-amyloid as a Marker for GBM Bioimaging

NCT05820191 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: AMY-GBM
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Glioblastoma

Keywords

Glioblastoma, Amyvid

Outcome Measures

Primary Outcomes (3)

• Measurement of Amyvid deposition in GBM tumor structures

  The Amyvid patterns of deposition (brightness or darkness patterns) will be analyzed in whole brain, tumor and peri-tumor resection region with and without representation of post-treatment modifications, as compared to MRI scans.

  Through study completion, an average of 1 year

• Correlation of Amyvid deposition with components of high metabolic activity.

  Association of Amyvid deposition patterns with brain tissue components of high and low metabolic activity will be analyzed as compared to MRS images.

  Through study completion, an average of 1 year

• Correlation of Amyvid deposition with components of increased vascularization.

  Association of Amyvid deposition patterns with areas of high and low vascularization will be analyzed as compared to MRP scans.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Correlation of Amyvid deposition and amyloid- β expression in GBM specimens.

  Through study completion, an average of 1 year

• Correlation of Amyvid deposition with characteristics of tumor vasculature in GBM specimens.

  Through study completion, an average of 1 year

Study Arms (1)

AMY-GBM

EXPERIMENTAL

Amyvid-PET scan will be performed. According to approved protocol for Alzheimer's disease diagnostics, 370MBq (10mCi) absorbed dose 7mSv of Amyvid will be introduced intravenously and 30-50 minutes after the PET images will be acquired.

Drug: Amyvid, Intravenous Solution

Interventions

Amyvid, Intravenous Solution DRUG

Amyvid 370MBq (10mCi) absorbed dose 7mSv of will be introduced intravenously and 30-50 minutes after the PET images will be acquired.

Also known as: Florbetapir-f18

AMY-GBM

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous allergic reaction to radioisotope tracers

Sponsors & Collaborators

• Universidad Central del Caribe: lead
• University of Puerto Rico: collaborator

Study Sites (2)

Central University of the Caribbean (UCC)

Bayamón, PR, 00956, Puerto Rico

Location

University of Puerto Rico, Medical Science Campus

San Juan, 0921, Puerto Rico

Location

Related Publications (3)

• Kucheryavykh LY, Ortiz-Rivera J, Kucheryavykh YV, Zayas-Santiago A, Diaz-Garcia A, Inyushin MY. Accumulation of Innate Amyloid Beta Peptide in Glioblastoma Tumors. Int J Mol Sci. 2019 May 20;20(10):2482. doi: 10.3390/ijms20102482.

  PMID: 31137462 BACKGROUND

• Zayas-Santiago A, Diaz-Garcia A, Nunez-Rodriguez R, Inyushin M. Accumulation of amyloid beta in human glioblastomas. Clin Exp Immunol. 2020 Dec;202(3):325-334. doi: 10.1111/cei.13493. Epub 2020 Aug 11.

  PMID: 32654112 BACKGROUND

• Kucheryavykh LY, Davila-Rodriguez J, Rivera-Aponte DE, Zueva LV, Washington AV, Sanabria P, Inyushin MY. Platelets are responsible for the accumulation of beta-amyloid in blood clots inside and around blood vessels in mouse brain after thrombosis. Brain Res Bull. 2017 Jan;128:98-105. doi: 10.1016/j.brainresbull.2016.11.008. Epub 2016 Nov 28.

  PMID: 27908798 BACKGROUND

MeSH Terms

Conditions

Glioblastoma

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Lilia Kucheryavykh, PhD

  Universidad Central del Caribe (Central University of the Caribbean)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lilia Kucheryavykh, PhD

CONTACT

7877983001; lilia.kucheryavykh@uccaribe.edu

Miguel Mayol Del Valle, MD

CONTACT

787-758-2525; miguel.mayol@upr.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 19, 2023
• Study Start: July 1, 2024
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PR (2)