Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06620380

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

Led by University of Zurich · Updated on 2026-01-09

102

Participants Needed

3

Research Sites

89 weeks

Total Duration

On this page

Sponsors

U

University of Zurich

Lead Sponsor

A

anticancerfund.org

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be 18 years or older on the day of signing the informed consent, female or male.
  • Patients must have a Karnofsky performance status of 60 or more.
  • Patients must have limited systemic therapeutic options as per treating physician judgement.
  • Patients with a tumor with a targetable oncogenic driver mutation should have already been treated with a targeted agent and options must have been exhausted.
  • Patients must have a clinical indication for surgery for probable brain metastasis.
  • Diagnosis of brain metastasis must be histologically confirmed on the sample obtained during surgery after signing informed consent.
  • Any type of primary cancer is allowed, including breast cancer, lung cancer, melanoma, and others.
  • Patients must have adequate bone marrow, renal, and hepatic function documented at screening before surgery.
  • Women of childbearing potential must have a negative urinary or serum pregnancy test.
  • Patients must be able to understand study requirements, provide written informed consent, and agree to study restrictions and assessments.
  • Written informed consent must be signed and dated prior to any study intervention.
Not Eligible

You will not qualify if you...

  • Patients with rapidly progressive systemic disease.
  • Patients unable to undergo brain MRI evaluation.
  • Patients with progressive parenchymal brain metastases requiring whole brain radiotherapy after surgery (focal radiotherapy allowed).
  • Patients judged unlikely to comply with study procedures and requirements.
  • Intention to become pregnant during the study.
  • Pregnant females.
  • Breastfeeding females who do not agree to stop nursing before treatment starts.
  • Sexually active males and females of childbearing potential unwilling to use effective contraception during the study.
  • Male participants who do not agree to abstain from sperm donation during the study.

AI-Screening

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Trial Site Locations

Total: 3 locations

1

University Hospital Basel

Basel, Switzerland

Not Yet Recruiting

2

Cantonal Hospital St Gallen

Sankt Gallen, Switzerland

Not Yet Recruiting

3

University Hospital Zurich

Zurich, Switzerland

Actively Recruiting

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Research Team

E

Emilie Le Rhun

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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