Ex Vivo Drug Response Evaluation for Next Generation Care of Brain Metastases

Sponsor
University of Zurich
Study ID
NCT06620380
Phase
PHASE2
Status
Recruiting
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Conditions

  • Brain Metastases
  • Brain Metastases, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pharmacoscopy 1.0 — DEVICE
    Pharmacoscopy is currently an academically developed platform. The study is designed to investigate the clinical performance of this academic platform. In the interventional arm, the best candidate agent defined by pharmascopy will be considered to guide the therapeutic decision for each patient.
  • Control — OTHER
    The next systemic treatment after surgery will be discussed, with the investigator and at the tumor board, considering also standard histopathological and molecular analysis, including next generation sequencing, molecular profiling analysis and previous treatments received

Study Details

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.

Key Dates

First listed
Oct 1, 2024
Start date
Sep 12, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: experimental arm, Pharmacoscopy-guided treatment
    Arm 1 (experimental arm): Pharmacoscopy-guided treatment will be prescribed by the investigator according to the results of the analysis (relevant on-target effect) and per drug prescription guidelines.
  • Active Comparator: Arm 2: control arm
    For patients randomized to the control arm, no pharmacoscopy analysis will be performed.

Primary Outcome Measure

Overall survival [ Time Frame: 8 months ]

Central Contacts

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