Implantable microdevice to test drug effects inside colorectal liver tumors
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
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 |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Lake Success, New York and 1 other locations) |
| Trial ID | NCT07193862 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Lake Success, New York and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.