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RECRUITING
NCT04135807
EARLY_PHASE1

Implantable Microdevice In Primary Brain Tumors

Sponsor: Oliver Jonas

View on ClinicalTrials.gov

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.

Official title: A Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Primary Brain Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2020-03-03

Completion Date

2028-06-01

Last Updated

2025-07-23

Healthy Volunteers

No

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.

Locations (1)

Brigham and Women's Hospital

Boston, Massachusetts, United States