Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients Wit… (NCT07193862) | Clinical Trial Compass
RecruitingEarly Phase 1
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
United States10 participantsStarted 2025-12-10
Plain-language 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, 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 unkn…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of adverse events (AEs) associated with Microdevice placement and retrieval