Clinical trial · Interventional
B-amyloid as a Marker for GBM Bioimaging
NCT05820191CI-TRIAL-00072456unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amyvid, Intravenous Solution | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AMY-GBM
- description
- 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.
- interventionNames
- Drug: Amyvid, Intravenous Solution
Primary outcomes (3)
- measure
- Measurement of Amyvid deposition in GBM tumor structures
- timeFrame
- Through study completion, an average of 1 year
- description
- 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.
- measure
- Correlation of Amyvid deposition with components of high metabolic activity.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDKucheryavykh 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
- BACKGROUNDZayas-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
- BACKGROUNDKucheryavykh 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