Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06620380
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-27
Brief Title:
Ex Vivo Drug Response Evaluation for Next Generation Care of Brain Metastases
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ex Vivo Drug Response Evaluation for Next Generation Care of Brain Metastases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EViDENCE-BM
Brief Summary:
Pharmacoscopy refers to an ex vivo real-time drug sensitivity profiling platform that has been shown to be of value in the treatment of leukemia Snijder et al 2017 Kornauth et al 2022 and may help to identify novel treatment opportunities for brain tumors as well Lee et al 2022 The rationale for pharmacoscopy-based drug sensitivity testing on real-time patient biopsies or surgery material is multiple measuring drug response and sensitivity directly in real-time patient material overcomes the problem of limited molecular biomarkers for established targeted therapeutic options and can identify effective drugs even for non-targeted therapies such as chemotherapy It can also identify hitherto unknown specific vulnerabilities of cancer cells Furthermore testing directly on patient material overcomes the limitations of patient-derived cell cultures organoids and patient xenografts as their prolonged culture times risk cellular adaptations and clonal selection that alter drug sensitivity Pharmacoscopy maintains the tumor cell composition including bystander cells or tumor microenvironment and limits cell culture to max 48 hours Furthermore pharmacoscopy measures drug responses on a single-cell and on a high-content level uniquely allowing to measure the drug sensitivity of tumor cells and allowing to compare it to the drug cytotoxicity on healthy cells from the same patient This relative readout has previously been shown to be essential for the correct prediction of a clinical response in haematological malignancies Snijder et al 2017 Kornauth et al 2022
The aim of this study is to generate preliminary data regarding superiority of the personalized pharmacoscopy-guided approach compared to a standard non-pharmacoscopy-guided approach in patients with brain metastases with an indication for surgery and limited therapeutic systemic options according to the treating physician
The aim of this study is to generate preliminary data regarding superiority of the personalized pharmacoscopy-guided approach compared to a standard non-pharmacoscopy-guided approach in patients with brain metastases with an indication for surgery and limited therapeutic systemic options according to the treating physician
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None