MedTrace Logo

Implantable Microdevice In Primary Brain Tumors

NCT04135807 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-07-23

No results posted yet for this study

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.

Conditions

  • Grade II Glioma
  • Grade III Glioma
  • Grade IV Glioma
  • Astrocytoma
  • Oligodendroglioma of Brain
  • Anaplastic Astrocytoma of Brain
  • Anaplastic Oligodendroglioma
  • Glioblastoma

Interventions

COMBINATION_PRODUCT

Microdevice

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 (Temozolomide, Lomustine, Irinotecan, Carboplatin, Lapatinib, Osimertinib, Abenaciclib, and Everolimus) released by the microdevice reservoirs. The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.

Sponsors & Collaborators

  • Oliver Jonas

    lead OTHER

Principal Investigators

  • Pier Paolo Peruzzi, MD, PhD · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2028-01-21
Completion
2028-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04135807 on ClinicalTrials.gov