Actively Recruiting
Implantable Microdevice In Primary Brain Tumors
Led by Oliver Jonas · Updated on 2025-07-23
12
Participants Needed
1
Research Sites
430 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Implantable Microdevice In Primary Brain Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have an operable supratentorial tumor presumed to be WHO grade II-IV glioma based on MRI, with planned surgical removal
- Histological confirmation of WHO grade II-IV glioma at surgery for newly diagnosed tumors or prior diagnosis from previous surgeries
- Participants must be 18 years of age or older
- Karnofsky Performance Score of 60 or higher
- Normal organ and marrow function as defined by specific blood counts and kidney/liver function tests
- Evaluation by a neurosurgeon confirming feasibility of microdevice implantation
- Women of childbearing potential must have a negative pregnancy test within 48 hours before enrollment
- Women and men must agree to use effective contraception during the study
- Ability to understand and sign informed consent
You will not qualify if you...
- Chemotherapy or radiotherapy within 4 weeks before the study (6 weeks for nitrosoureas) or not recovered from related side effects
- Receiving other investigational agents
- History of allergic reactions to similar compounds as the microdevice or study drugs
- Uncontrolled illnesses such as active infections, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions affecting compliance
- Pregnant or breastfeeding women
- Tumor size smaller than 5 cubic centimeters
- Tumor located in deep brain areas like the thalamus or brainstem
- Uncorrectable bleeding or clotting disorders increasing surgical risk
- Significant risk factors preventing safe stopping of blood-thinning medication as per guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
P
Pier Paolo Peruzzi, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here