Status:
NOT_YET_RECRUITING
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
Lead Sponsor:
Northwell Health
Conditions:
Colorectal Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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, pha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07193862
Start Date
October 15 2025
End Date
April 15 2026
Last Update
September 26 2025
Active Locations (1)
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1
RJ Zuckerberg
Lake Success, New York, United States, 11042