ACTIVE_NOT_RECRUITING

Pressure-enabled Delivery in Radioembolization (TriNav Study)

Conditions

Liver Cancer Hepatocellular Carcinoma Metastatic Colorectal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to determine if the type of catheter used in the mapping procedure prior to radioembolization improves the delivery of radioactivity to tumor(s) in participants with liver cancer. The name of the devices involved in this study are: * Pressure Enabled Drug Delivery (PEDD)/TriNav Infusion System * Standard 2.4F microcatheter, not otherwise specified

Official Title

A Prospective, Randomized, Open-Label Study to Examine The Effects of a Pressure-Enabled Drug Delivery Device on Radiotracer Distribution Compared to a Standard Microcatheter in the Context of Radioembolization

Quick Facts

Study Start:2022-03-01

Study Completion:2026-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05128032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Patrick D Sutphin, MD, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02245

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Patrick D Sutphin, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-01

Study Completion Date2026-06-01

Study Record Updates

Study Start Date2022-03-01

Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

Liver Cancer
Hepatocellular Carcinoma
Metastatic Colorectal Cancer

Additional Relevant MeSH Terms

Liver Cancer
Hepatocellular Carcinoma
Metastatic Colorectal Cancer