Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis

Part of paid clinical trials in Lake Success, New York.

Sponsor
Northwell Health
Study ID
NCT07193862
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Doxorubicin, FOLFOX, Botensilimab, Balstilimab, Bevacizumab, FOLFIRI, FOLFIRINOX, AGEN2373 — COMBINATION_PRODUCT
    Patients with diagnosed liver metastasis from a colorectal primary deemed resectable. The study intervention will be limited to the percutaneous placement of up to 2 IMDs per lesion with a maximum of 4 devices total, with the subsequent en bloc resection of the tumor plus IMD within 3 (+2) days after placement. The microdevices will remain in the tumor for a minimum of a 2-day incubation period, although ideally for 3 days. The IMD is a small cylindrical device approximately 750 um in diameter and 5 mm in length (Figure 2), housing up to 21 reservoirs. It is made of PEEK, biocompatible material used in other implantable constructs, including joint replacements. 11-13 Drugs are solubilized with poly-ethylene glycol (PEG) and loaded into the individual reservoirs. The drug diffusion has been mapped extensively to ensure that the weight of PEG is selected such that drug diffusion is limited and will not mix or interfere with another drug.

Study Details

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.

Key Dates

Start date
Dec 10, 2025
Status verified
Feb 2026
Primary completion
Apr 15, 2026
Completion
Apr 15, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Subjects will have the device placed loaded with chemotherapeutic agents.

Primary Outcome Measure

Incidence of adverse events (AEs) associated with Microdevice placement and retrieval [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
RJ ZuckerbergLake SuccessNew York11042
Micaela Wigfall Maxwell
[email protected]
516-465-1910
Long Island Jewish Medical CenterNew Hyde ParkNew York11040
Micaela Wigfall

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By research site
RJ Zuckerberg· Lake Success, NYLong Island Jewish Medical Center· New Hyde Park, NY

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