B-amyloid as a Marker for GBM Bioimaging

December 20, 2023 updated by: Lilia Kucheryavykh, Universidad Central del Caribe
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

3

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Puerto Rico
      • Bayamon, Puerto Rico, 00956
        • Central University of the Caribbean (UCC)
        • Contact:
        • Principal Investigator:
          • Lilia Kucheryavykh, PhD
      • San Juan, Puerto Rico, 0921
        • University of Puerto Rico, Medical Science Campus
        • Contact:
        • Sub-Investigator:
          • Miguel Mayol Del Valle, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMY-GBM
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
Amyvid 370MBq (10mCi) absorbed dose 7mSv of will be introduced intravenously and 30-50 minutes after the PET images will be acquired.
Other Names:
  • Florbetapir-f18

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Amyvid deposition in GBM tumor structures
Time Frame: Through study completion, an average of 1 year
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.
Time Frame: Through study completion, an average of 1 year
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.
Time Frame: Through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of Amyvid deposition and amyloid- β expression in GBM specimens.
Time Frame: Through study completion, an average of 1 year
Tissue specimens, separated from total tumor after planned surgical resection and prior Amyvid-PET analysis, will be analyzed by western blot to quantify amyloid-β expression level and correlate with deposition of Amyvid, as identified by Amyvid-PET.
Through study completion, an average of 1 year
Correlation of Amyvid deposition with characteristics of tumor vasculature in GBM specimens.
Time Frame: Through study completion, an average of 1 year
Tissue specimens, separated from total tumor after planned surgical resection and prior Amyvid-PET analysis, will be analyzed with use of immunofluorescence imaging of blood vessels to characterize tumor vasculature structure (as capillary density and diameter) and correlate with deposition of Amyvid, as identified by Amyvid-PET.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Central del Caribe

Collaborators

University of Puerto Rico

Investigators

  • Principal Investigator: Lilia Kucheryavykh, PhD, Universidad Central del Caribe (Central University of the Caribbean)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 13, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMY-GBM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Investigation will be performed on anonymous basis in order to protect the confidentiality of the subjects.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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