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GlioblastomaPhase 2NCT05820191

B-amyloid as a Marker for GBM Bioimaging

A Phase 2 study testing Amyvid, Intravenous Solution in people with Glioblastoma, run by Universidad Central del Caribe at 2 sites in Puerto Rico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Amyvid, Intravenous Solution
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesPuerto Rico
Study dates
Jul 2024to Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Previous allergic reaction to radioisotope tracers

Trial locations and contacts

2 sites in 1 country.

Lilia Kucheryavykh, PhD contact

7877983001 ext. 2037

lilia.kucheryavykh@uccaribe.edu

Miguel Mayol Del Valle, MD contact

787-758-2525

miguel.mayol@upr.edu

Puerto Rico2 sites

  • Central University of the Caribbean (UCC)

    Bayamón, PR, 00956

    Lilia Kucheryavykh, PhD, 7877983001 ext. 2037, lilia.kucheryavykh@uccaribe.edu

    Lilia Kucheryavykh, PhD

  • University of Puerto Rico, Medical Science Campus

    San Juan, 0921

    Miguel Mayol Del Valle, MD, 787-758-2525, miguel.mayol@upr.edu

    Miguel Mayol Del Valle, MD

Other trials in Puerto Rico

About this study

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.

Read the 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
Being tested
Amyvid, Intravenous Solution
Keywords
Glioblastoma, Amyvid
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amyvid, Intravenous SolutionDrug

    Also called Florbetapir-f18

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

Study groups in NCT05820191
Study groupRoleWhat they receive
AMY-GBMExperimentalAmyvid-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.
Receives: Drug: Amyvid, Intravenous Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 1 year

  2. 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.

    Measured: Through study completion, an average of 1 year

  3. 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.

    Measured: Through study completion, an average of 1 year

Secondary outcomes (2)

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

    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.

    Measured: Through study completion, an average of 1 year

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

    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.

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2023
  2. Study startJul 2024 (estimated)
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
3 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05820191
Sponsor's protocol ID
AMY-GBM
Status last verified
Dec 2023
First submitted
13 Mar 2023
Last updated
21 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Investigation will be performed on anonymous basis in order to protect the confidentiality of the subjects.

Publications

  • 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.

    PubMed 31137462

  • 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.

    PubMed 32654112

  • 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.

    PubMed 27908798

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amyvid, Intravenous Solution in people with Glioblastoma, run by Universidad Central del Caribe at 2 sites in Puerto Rico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lilia Kucheryavykh, PhD (7877983001 ext. 2037, lilia.kucheryavykh@uccaribe.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of Amyvid deposition in GBM tumor structures (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05820191, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.

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B-amyloid as a Marker for GBM Bioimaging (NCT05820191) | AzTrials