Implantable Microdevice In Primary Brain Tumors
This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in malignant brain tumors. * The device involved in this study is called a microdevice. * The drugs used in this study will only include dr
| Condition(s) | Grade II Glioma, Grade III Glioma, Grade IV Glioma, Astrocytoma, Oligodendroglioma of Brain, Anaplastic Astrocytoma of Brain, Anaplastic Oligodendroglioma, Glioblastoma |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in malignant brain tumors. * The device involved in this study is called a microdevice. * The drugs used in this study will only include drugs already used systemically for the treatment of gliomas. |
| Who can participate | Inclusion Criteria: * Patients must have operable supratentorial tumor presumed to be WHO grade II-IV glioma (Astrocytoma, Oligodendroglioma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, or Glioblastoma) based on radiological evidence at MRI, where a gross total or partial surgical resection is intended. * Histological confirmation of WHO grade II-IV glioma at time of intraoperative frozen analysis (for newly diagnosed tumors). This is not necessary in cases where a histopathologic diagnosis is already available from prior surgeries/biopsies. * Participants must be 18 years of age or older. * Karnofsky Performance Score ≥ 60 (Appendix C). * Participants must have normal organ and marrow function as defined below: * Leukocytes ≥ 3,000/mcL * Absolute neutrophil count ≥ 1,500/mcL * P |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Oliver Jonas |
| Locations | Boston, Massachusetts, United States |
| Start date | 2020-03-03 |
| NCT ID | NCT04135807 |
| Official listing | https://clinicaltrials.gov/study/NCT04135807 |