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Microdevice for Brain Cancer

Phase < 1
Recruiting
Led By Pier Paolo Peruzzi, MD, PhD
Research Sponsored by Oliver Jonas, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights

Summary

This trial will test the safety and feasibility of using a microdevice to measure local response to chemotherapy and other drugs in brain tumors.

Who is the study for?
Adults with operable brain tumors (WHO grade II-IV gliomas) who can have a microdevice implanted. They must not have had recent chemotherapy or radiotherapy, be on certain enzyme inhibitors, and women must test negative for pregnancy and agree to contraception. Excluded are those with allergies to similar compounds, uncontrolled illnesses, small tumors (<5 cm3), deep brain tumor location, or risks preventing safe anticoagulation cessation.Check my eligibility
What is being tested?
The trial is testing the safety of an implantable microdevice that measures how well different drugs work inside malignant brain tumors. These drugs are already approved for treating gliomas but will be delivered locally by the device during surgery.See study design
What are the potential side effects?
Potential side effects may include reactions related to surgical implantation such as infection at the site of surgery, bleeding complications due to the procedure itself or interactions with other medications affecting blood clotting.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Microdevice Related Adverse Events as Assessed by CTCAE Volume 5.0
Success Rate of Microdevice Retrieval
Secondary outcome measures
Correlate Tissue Genetic Features with Drug Response
Measure Local Intratumor Response to Different Agents

Trial Design

1Treatment groups
Experimental Treatment
Group I: MicrodeviceExperimental Treatment1 Intervention
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Patients with newly found supratentorial lesions, or patients previously diagnosed with supratentorial gliomas at time of recurrence, whose treatment plan includes partial or total resection surgery as a component of standard-of-care treatment will be included. - Placement of 1-3 microdevices (depending on the size of the tumor) before tumor resection is started. -- The microdevices will dwell in the tumor tissue for a time window of 2-4 hours to allow time for tissue effects of the drugs microdoses for intratumor release of the following 8 approved drugs: Temozolomide, Lomustine, Irinotecan, Carboplatin, Lapatinib, Osimertinib, Abenaciclib, and Everolimus. The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.

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Who is running the clinical trial?

Oliver Jonas, PhDLead Sponsor
Oliver JonasLead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
Pier Paolo Peruzzi, MD, PhDPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Microdevice (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04135807 — Phase < 1
Glioblastoma Research Study Groups: Microdevice
Glioblastoma Clinical Trial 2023: Microdevice Highlights & Side Effects. Trial Name: NCT04135807 — Phase < 1
Microdevice (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04135807 — Phase < 1
~2 spots leftby Jul 2025