Actively Recruiting
Pilot Study of an Implantable Microdevice for Drug Response Evaluation in Metastatic Renal Cell Carcinoma
Led by Oliver Jonas · Updated on 2026-05-18
20
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
O
Oliver Jonas
Lead Sponsor
D
Dana-Farber Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and feasibility of implanting and removing a tiny device that releases small doses of 19 different cancer drugs or drug combinations to help evaluate how these drugs work against metastatic renal cell carcinoma (RCC). This pilot research involves drugs already used as standard care for metastatic RCC and some approved for other cancers but being tested for RCC. The study aims to provide a new tool to assess drug effectiveness directly within tumors. The study involves placing one or more microdevices, each small enough to fit inside a needle tip, into tumors. These devices release microdoses of drugs locally into tumor tissue by passive diffusion. After about three days, the microdevices and surrounding tumor tissue are surgically removed during a standard-of-care operation. Participants will receive standard treatments for metastatic RCC alongside the implant procedure. The process includes implantation 72 hours before surgery and surgical removal of the device and tissue at surgery time. Participants will undergo screening, imaging, blood tests, tumor biopsies, and follow-up visits over approximately four months. Researchers will monitor safety during hospital stays and follow-up visits, focusing on safety of device implantation and procedure feasibility within 30 days and 72 hours respectively. Data from tumor tissue and drug response will be analyzed. The study expects about 20 participants to take part in two cohorts, with monitoring continuing after surgery to ensure safety and collect outcome data.
CONDITIONS
Brief Title
Drug Screening Using Novel IMD in Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be able to understand and willing to sign informed consent.
- Confirmed or suspected localized or metastatic renal cell carcinoma.
- Planned for nephrectomy or metastatectomy as part of clinical care.
- Tumor lesion planned for excision must be at least 1 cm in size.
- Age 18 years or older.
- Evaluated by a medical oncologist for appropriate treatment strategy.
- Medically stable to undergo percutaneous procedures and surgery.
- Laboratory tests within 30 days prior to procedure meeting specific blood count and clotting criteria.
- CT or MRI assessing disease extent done as part of standard care.
- Case reviewed by interventional radiology and surgical teams for clinical stability, disease volume, and suitability for device implantation and removal.
- Willing to undergo research-related genetic sequencing and data management.
You will not qualify if you...
- Uncontrolled illnesses such as active infection, symptomatic congestive heart failure, unstable angina, unstable arrhythmia, or psychiatric/social issues limiting biopsy or surgery safety.
- Uncorrectable bleeding or clotting disorders increasing surgical or biopsy risks.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 days
Participants have 1 to 6 microdevices implanted into a tumor 72 +/- 24 hours prior to their scheduled standard-of-care surgery.
1 visit for implantation
Duration - Surgery day
At the time of standard-of-care surgery, the microdevices along with surrounding tumor tissue are surgically removed.
1 surgical visit (inpatient)
Duration - Up to 30 days
Participants are monitored for safety during their inpatient stay and at a follow-up clinic visit after surgery.
Approximately 1 inpatient stay and 1 follow-up clinic visit
Trial Site Locations
Total: 1 location
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
W
Wenxin Xu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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