Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
3 participants
INTERVENTIONAL
2024-07-31
2026-07-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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University of Puerto Rico
OTHER
Universidad Central del Caribe
OTHER
Responsible Party
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Lilia Kucheryavykh
Associate Professor
Principal Investigators
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Lilia Kucheryavykh, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Central del Caribe (Central University of the Caribbean)
Locations
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Central University of the Caribbean (UCC)
Bayamón, PR, Puerto Rico
University of Puerto Rico, Medical Science Campus
San Juan, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Lilia Kucheryavykh, PhD
Role: primary
Miguel Mayol Del Valle, MD
Role: primary
References
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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.
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.
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.
Other Identifiers
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AMY-GBM
Identifier Type: -
Identifier Source: org_study_id