New catheter may sharpen radiation targeting in liver tumors
NCT ID NCT05128032
First seen Jun 24, 2026 · Last updated Jul 21, 2026 · Updated 5 times
Summary
This study compares two catheters used during the mapping step before radioembolization for liver cancer. One is a standard microcatheter, the other is a pressure-enabled device (TriNav). The goal is to see if the pressure-enabled catheter delivers more radioactive tracer directly to tumors rather than to healthy liver tissue. Twenty adults with liver cancer (hepatocellular carcinoma or colorectal metastases) who are already scheduled for radioembolization will participate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TriNav Infusion System (pressure-enabled drug delivery catheter)
- What this could lead to
- If successful, this could show that a special catheter delivers radiation more precisely to liver tumors, potentially improving future radioembolization treatments.
- What could go wrong
- This is a small, early-phase study with only 20 participants, so results may not apply to all patients. It measures imaging outcomes, not actual treatment success or survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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29 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Jul 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Known HCC or CLM that are not amenable to curative resection or thermal ablative techniques such as microwave ablation. * Prior clinical decision for treatment by radioembolization. * Disease that is visible on CT or MRI as well as measurable disease in the liver. Measurable is defined as at least one lesion in the expected treatment field that can be accurately measured in at least one dimension (longest diameter) as (≥1 cm) with CT scan or MRI. * Age ≥18 years. Because there is limited data with respect to radioembolization in patients \<18 years of age with respect to tumor dosimetry and associated adverse events participants \<18 years of age, children are excluded from this study. * ECOG performance status \< 2 (Karnofsky ≥60%, see Appendix A). * Life expectancy \>16 weeks. * Suitable target artery diameter(s), defined in the TriNav labelling as 1.5 to 3.5mm vessels, based upon pre-procedural imaging. * Adequate organ and marrow function as defined below: * International Normalized Ratio (INR): ≤ 1.5 * Hemoglobin: ≥ 8.5 g/dL * Leukocytes: ≥2,000/mcL * Absolute neutrophil count: ≥1,00/mcL * Platelets: ≥50,000/mcL(after transfusion, if necessary) * Total bilirubin: ≤2.0 mg/dL * Albumin: ≥3 g/dL * AST(SGOT)/ALT(SGPT): ≤6 × institutional ULN * Glomerular filtration rate (GFR): 30 mL/min/1.73 m2 * Child Pugh Score A, or B7 with bilirubin ≤ 2 mg/dL. * If extrahepatic disease is present (e.g. brain metastases), such disease must be stable, under treatment, or not an imminent threat to the patient's life or quality of life. * Ability to understand and the willingness to sign a written informed consent document. * Prior to study entry women of child-bearing potential must agree to not become pregnant, nurse a baby, or use any milk expressed for 2 weeks following radioembolization. Men must agree to not father a baby for 2 months after treatment with radioembolization (This is confirmed during the consenting process and documented when the patient signs the informed consent form. The effects of Yttrium-90 and radiation associated with the procedures, radiotracers, and subsequent imaging are known to have teratogenic effects on the developing human fetus. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother breastfeeding should be discontinued for the duration of study participation.) * For HCC patients: Barcelona Clinic Liver Cancer Stage: A, B, C. Exclusion Criteria: * Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. * Unresolved toxicities related to cancer therapy that the investigator will continue and compromise patient safety. * History of hepatic encephalopathy; history of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be managed medically. * Uncontrolled intercurrent illness. * Psychiatric illness/social situations that would limit compliance with study requirements. * Prior external beam radiation treatment to the liver or prior intra-arterial liver-directed therapy including transarterial bland embolization, chemoembolization or radioembolization. * Contraindications to angiography and selective visceral catheterization, including bleeding diathesis or uncorrectable coagulopathy. * \> 50% of tumor involvement of the liver. * Receipt of intervention for the Ampulla of Vater or compromise thereof. * Child-Pugh B8 or greater. * Evidence of thrombosis in the main portal vein. * For CLM patients: evidence of cirrhosis or portal hypertension. * For CLM: Clinically-evident ascites other than trace noted on imaging.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02245, United States
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
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