Actively Recruiting
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
Led by Northwell Health · Updated on 2026-02-27
10
Participants Needed
2
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Microdevices have been used to ascertain in vivo drug response, which can lead to improved cancer treatment delivery; however, they have not been evaluated for liver tumors. This is a prospective, phase 1 safety study of percutaneous placement and surgical retrieval of a microdevice in patients with liver metastasis from colorectal cancer. The device will be implanted percutaneously 3-5 days prior to scheduled resection of colorectal liver metastasis (CLM) and then removed en bloc with the tumor. Patients will be monitored to ensure that the device's placement and retrieval does not result in increased complication rates within 14 days of surgery. To assess feasibility, the tissue surrounding the microdevice will be analyzed to assess the diffusion of the drugs from the device into the tissue and whether the therapeutic effect of diffusing chemotherapy +/- immune-modulating drugs has an impact on the surrounding tissue.
CONDITIONS
Official Title
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colorectal cancer with suspected liver metastasis on imaging
- Liver tumor 2 cm or larger on CT or MRI
- Planned surgery to remove liver tumor as part of standard care
- 18 years of age or older
- Normal blood counts and organ function as defined by study thresholds
- Suitable for microdevice implantation based on tumor location and clinical evaluation
- Negative pregnancy test within 48 hours before surgery for women of childbearing age
- Ability and willingness to provide informed consent
- Use of effective contraception during and after study as specified
- Agreement to stop breastfeeding for 14 days after microdevice insertion for nursing mothers
You will not qualify if you...
- Tumor location not suitable for device placement
- Pregnancy at the time of enrollment or surgery
- Prior or concurrent second primary cancer that may affect safety or study results
- Presence of extra-hepatic disease or unresectable liver metastasis on imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
RJ Zuckerberg
Lake Success, New York, United States, 11042
Actively Recruiting
2
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Actively Recruiting
Research Team
M
Micaela Wigfall Maxwell
CONTACT
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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