Implantable Microdevice in Primary Brain Tumors

This study is testing a small implantable device, called a microdevice, in people with certain types of brain tumors (Grade II, III, or IV glioma, astrocytoma, or oligodendroglioma). The microdevice is placed in the tumor during surgery for 2-4 hours and releases small amounts of drugs like Temozolomide, Lomustine, Irinotecan, Carboplatin, and Lapatinib. The goal is to see if this device can safely help doctors understand which drugs work best for an individual's tumor. You may be able to join if you are 18 or older, have an operable brain tumor, and are planning to have surgery to remove it. The study will measure how successfully the microdevice is removed and if there are any side effects. The current status of this study is unclear, and it plans to enroll about 12 people.

Study design: This is a pilot study, which means it's the first time this device is being examined in brain tumors. It aims to enroll about 12 participants.
What's involved: You would be in this research study for up to 30 days. The microdevice is inserted into the tumor during surgery and removed at the end of the surgery.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoints are measured at 1 day after the microdevice is used.

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Implantable Microdevice In Primary Brain Tumors

Recruiting

EARLY_PHASE1Ages 18+InterventionalDiagnostic

Oliver Jonas

~12 participants

Updated 2025-07-23 on ClinicalTrials.gov

What's tested:Microdevice

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Success Rate of Microdevice Retrieval

Measured over 1 day

+1 more outcome measured

Conditions

Grade II Glioma

Grade III Glioma

Grade IV Glioma

Astrocytoma

Oligodendroglioma of Brain

Anaplastic Astrocytoma of Brain

Anaplastic Oligodendroglioma

Glioblastoma

Where it's being run

1 sites across 1 states

Massachusetts1

Study leadership

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

Who to contact

Pier Paolo Peruzzi, MD, PhD

[email protected]

617-732-6600

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Platelets ≥ 100,000/mcL

Total bilirubin within normal institutional limits

AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal

Creatinine within normal institutional limits OR

Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.

Participants must be evaluated by a neurosurgeon who will determine the feasibility of microdevice implantation based on clinical history, extent, and anatomical location of the tumor.

Because participants will be exposed to microdoses of therapeutic agents only in a localized setting and for a short period of time (2-4 hours), the risk of interaction with other drugs routinely assumed by participants is considered not applicable. Thus, participants receiving any medications or substances that are inhibitors or inducers of CYP450 enzymes remain eligible.

The effects of the microdevice on the developing human fetus are unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential must agree to have a negative serum pregnancy test within 48 hours prior to registration. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.

Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.

Participants who are receiving any other investigational agents.

History of allergic reactions attributed to compounds of similar chemical or biologic composition to the microdevice or any agents used in the study.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant women are excluded from this study because agents released by the microdevice have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents used in this study, breastfeeding should be discontinued if the mother is treated in the study for a total of 14 days after removal of the microdevice.

Tumor size \< 5 cm3.

Tumor located in deep brain structures (e.g. thalamus, brainstem).

Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical procedures.

If there are significant risk factors (e.g. high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines, patients will be excluded from the trial.

What this trial measures

Success Rate of Microdevice Retrieval1 day
Defined as the ability to retrieve the microdevice with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of at least 50% of the microdevice reservoirs.
Number of Participants with Microdevice Related Adverse Events as Assessed by CTCAE Volume 5.01 Day
Failure" from a safety standpoint will be considered any of the following: * Any grade 3 or higher adverse events associated with microdevice placement or retrieval. * Any combination of more than two grade 2 adverse events. Failure" from a safety standpoint will be considered any of the following:

Trialytics