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New treatment option for Brain Metastases
Official title Ex Vivo Drug Response Evaluation for Next Generation Care of Brain Metastases
ClinicalTrials.gov ID: NCT06620380
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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. The number of previous lines of therapies is not limited.
- Patients with a tumor with a targetable oncogenic driver mutation should have already been treated with a targeted agent and options must have been...
- Patients must have a clinical indication for surgery for probable brain metastasis
You likely can't join if
- Patients with rapidly progressive systemic disease
- Patients with inability to undergo brain MRI evaluation.
- Patients with progressive parenchymal brain metastases with an indication for requiring whole brain radiotherapy after surgery. Focal brain...
- Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.
- Intention to become pregnant during the course of the study.
- Female who are pregnant.
See the full eligibility criteria
- 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. The number of previous lines of therapies is not limited.
- 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
- Patients will be considered eligible for the study only if the diagnosis of brain metastasis has been histologically confirmed on the sample obtained during the surgery performed after signing the informed consent form...
- Any type of primary cancer is allowed: breast cancer, lung cancer, melanoma, other cancers. Patients may have several primary cancers.
- Patients must have adequate bone marrow, renal and hepatic function documented at screening before surgery
- Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test
- Patients must have the ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study...
- Written informed consent for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.
- Patients with rapidly progressive systemic disease
- Patients with inability to undergo brain MRI evaluation.
- Patients with progressive parenchymal brain metastases with an indication for requiring whole brain radiotherapy after surgery. Focal brain radiotherapy after surgery is allowed.
- Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.
- Intention to become pregnant during the course of the study.
- Female who are pregnant.
- Female who are breastfeeding and who do not agree to discontinue nursing prior to the first treatment initiated during the study.
- Sexually active males and females of childbearing potential who are not willing to use an effective contraceptive method during the study. Male participants who do not agree not to donate sperm.
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
- Sankt Gallen, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland; Sankt Gallen, Switzerland; Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.