Implantable microdevice to test drug effects inside colorectal liver tumors
Official title: Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
Run by Northwell Health · NCT07193862 · Data updated 2026-11-12
This will try placing a tiny implant into liver metastases to see if different cancer drugs diffuse into and affect the tumor tissue in adults scheduled for surgery for colorectal cancer spread to the liver.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Lake Success, New York and 1 other locations) |
| Status | Recruiting |
| Started | December 10, 2025 |
| Main results expected | April 15, 2028 |
| Study ends | April 15, 2028 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT07193862 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically confirmed colorectal cancer and at least one liver metastasis ≥2 cm on imaging who are planned for hepatectomy and meet required organ and marrow function are ideal candidates.
✕Probably not a fit
Patients who are not undergoing surgical resection, have tumors smaller than 2 cm, have inadequate blood counts or organ function, are pregnant, or whose tumor location prevents safe device placement are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective phase 1 safety pilot in which a small microdevice is placed percutaneously into a colorectal liver metastasis 3–5 days before a planned hepatectomy and removed en bloc with the tumor at surgery. The procedure is monitored for procedural and surgical complications, with specific safety follow-up in the 14 days after surgery. Retrieved tissue around the device will be analyzed to measure drug diffusion from the device and any local therapeutic or tissue effects from exposed chemotherapy and immune-modulating agents. Multiple standard chemotherapy regimens and investigational immune agents may be loaded in the device to characterize in situ responses in liver metastases.
Why it matters
Potential benefit: If successful, this approach could help doctors see which drugs work in an individual patient’s liver metastasis before giving full systemic therapy, enabling more personalized treatment choices.
How similar studies have gone: Similar implantable microdevice methods have been used to measure local drug response in other solid tumors, but this is the first prospective safety evaluation focused on liver metastases from colorectal cancer.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed colorectal cancer with suspicion of liver metastasis on imaging Liver tumor ≥2 cm on preoperative imaging via computed tomography (CT) or magnetic resonance imaging (MRI) Planned hepatectomy as part of standardized treatment plan, irrespective of study enrollment ≥18 years of age Normal organ and marrow function, defined as follows: * Leukocytes ≥3,000/mcL * Absolute neutrophil count ≥1500/mcL * Platelets ≥ 100,000/mcL * PT≤ 14, PTT≤ 38, INR ≤ 1. * Creatinine within normal institutional limits OR clearance ≥60mL/min/1.73m2 Feasibility of microdevice implantation based on clinical history as well as extent and anatomical location of the CLM tumor as evaluated by the operating surgical oncologist and interventional radiologist on baseline imaging The effects of the microdevice on a developing human fetus are unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of childbearing age must agree to have a negative serum pregnancy test within 48 hours of their operation Ability to understand and willingness to sign informed consent for both the surgical resection and the proposed research study prior to any procedures Males and females of childbearing potential must agree to use effective contraception starting before the first day of treatment and continuing for at least 3 months (men) or 6 months (women) after implantation of the microdevice. Additionally, due to the unknown but potential risks of nursing infants secondary to the treatment of the mother with the chemotherapeutic agents of the study, mothers must agree to discontinue breastfeeding for a total of 14 days after the insertion of the microdevice. Exclusion Criteria: Tumor location not amenable to device placement Pregnancy at the time of enrollment or operation due to the known teratogenicity of the medications involved. Prior or concurrent second primary malignancy whose natural history or treatment has the potential to interfere with the safety or primary endpoint efficacy assessment of the CLM Extra-hepatic disease or unresectable liver metastasis on baseline imaging
Where it's running
-
RJ Zuckerberg
Lake Success, New York, United States Recruiting -
Long Island Jewish Medical Center
New Hyde Park, New York, United States Recruiting
Study contacts
- Study coordinator: Micaela Wigfall Maxwell
- Email: MWigfallMaxw@northwell.edu
- Phone: 833-223-4732
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.