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Studying a Microdevice for Kidney Cancer Drug Screening

This study is testing a small, implantable device (Implantable Microdevice or IMD) that releases tiny amounts of cancer drugs directly into a tumor. The goal is to see if this device is safe to use and if it can help doctors understand which drugs work best against kidney cancer (renal cell carcinoma). The drugs used in the device are already approved for cancer treatment, including Cabozantinib, Pazopanib, and others. You might be able to join if you have confirmed or suspected kidney cancer that is at least 1cm in size and are planning to have surgery to remove part of your kidney or a tumor. The study will look at how safe the device is for up to 30 days and if it can be successfully placed within 72 hours. The current status of the study is unclear.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is a pilot study focused on safety and feasibility.
What's involved
You would undergo screening, imaging, evaluations, blood collections, tumor biopsies, and follow-up visits. The microdevice would be implanted for about 3 days before removal. Your participation is expected to last up to 4 months.
Compensation
Not stated in the trial record.
Follow-up
The study will track the safety of the microdevice for up to 30 days after implantation.

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NCT05700461

Drug Screening Using Novel IMD in Renal Cell Carcinoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Oliver Jonas
~20 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Implantable Microdevice (IMD)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of microdevice implantation
Measured over Up to 30 days
+1 more outcome measured

Conditions

Renal Cell Carcinoma
Metastatic Renal Cell Carcinoma
Kidney Cancer

Explore related trials

Renal Cell Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Wenxin Xu, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Wenxin Xu, MD
[email protected]
617-632-6534
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 the ability to understand and the willingness to sign a written informed consent document.
Participants must have confirmed or suspected localized or metastatic renal cell carcinoma, and must be planned for either nephrectomy or metastatectomy as part of their clinical care. The lesion planned for excision must be at least 1cm in size.
Participants must be 18 years of age or older.
Participants must be evaluated by a medical oncologist who will determine the clinically appropriate treatment strategy based on clinical history and extent of disease.
Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures.
Participants will undergo laboratory testing within 30 days prior to the procedure (or within 72 hours if there has been a change in the clinical status since the initial blood draw). Patients must have absolute neutrophil count ≥1,000/mcL, platelets ≥50,000/mcL, INR \< 1.5 and PTT \<1.5x control.
Participants must have undergone CT or MRI that assesses the extent of disease and allows the research team to assess for study eligibility. This will have been done as part of the standard-of-care.
The participant's case must be reviewed by representatives of interventional radiology and the appropriate surgical subspecialty to assess the following factors:
Patient is clinically stable to undergo microdevice implantation and surgical procedures
Patient has sufficient volume of disease to allow implantation of the microdevice
Patient has a lesion for which the microdevice is a) amenable to percutaneous placement, and b) amenable to removal at the time of surgery
Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.

Exclusion

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or biopsy procedures (detailed below).

What this trial measures

  • Safety of microdevice implantationUp to 30 days

    * Any grade 3-5 adverse events likely or definitely attributable to device placement or retrieval * Any death attributable to the study procedures and not attributable to the underlying malignancy or external causes * Any device resulting in major adverse events as defined in the protocol

  • Number of Patients with Feasible Microdevice Procedure72 hours

    For Cohort 1, this is defined as technical success of microdevice placement and successful retrieval of the microdevice from the surgery specimen with sufficient amount and quality of tissue for histopathology analysis and interpretation of at least 50% of the microdevice reservoirs. For Cohort 2, feasibility is defined as successful microdevice placement and the successful retrieval of at least one microdevice per patient with sufficient amount and quality of tissue for histopathology analysis and interpretation of at least 50% of the reservoirs on that microdevice.