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TriNav Infusion System for Liver Cancer
N/A
Recruiting
Led By Armeen Mahvash, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial evaluates if the TriNav catheter improves accuracy of radioembolization procedure, compared to a standard catheter.
Who is the study for?
This trial is for adults over 18 with inoperable liver tumors, either primary or metastatic. Participants must have a life expectancy of at least 3 months, an ECOG score ≤2 (which means they can do some activities), and not be pregnant. They should also have at least one tumor that's ≥3 cm big. People who can't undergo angiography or might get too much radiation to their lungs from the treatment cannot join.Check my eligibility
What is being tested?
The study tests if the TriNav Infusion System improves matching between a test dose and actual radioactive microsphere distribution during radioembolization for liver cancer compared to standard catheters. It aims to see if this system leads to better planning and outcomes.See study design
What are the potential side effects?
Possible side effects include those related to angiogram procedures like bleeding or bruising at the insertion site, allergic reactions to contrast dye, and complications from Y90-radioembolization such as fatigue, abdominal pain, nausea, fever, or potential radiation exposure risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Trial Design
1Treatment groups
Experimental Treatment
Group I: TriSalus™ TriNav™Infusion System (catheter)Experimental Treatment3 Interventions
TriNav Infusion System (TriNav catheter) for the injection of the surrogate/test dose during the planning part of the radioembolization procedure and your actual treatment with the radioactive microspheres match each other better than the standard catheter
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Angiogram
2021
Completed Early Phase 1
~10
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,454 Total Patients Enrolled
21 Trials studying Liver Cancer
9,396 Patients Enrolled for Liver Cancer
TriSalus Life SciencesUNKNOWN
3 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Liver Cancer
20 Patients Enrolled for Liver Cancer
Armeen Mahvash, MDPrincipal InvestigatorM.D. Anderson Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot undergo angiography or selective visceral catheterization due to health risks.My tumor is spreading into surrounding tissues.My treatment plan includes a single injection that delivers more than 30 Gy to the lungs.I am not pregnant.My scans show no signs of tracer flow to my stomach or duodenum after certain procedures.I am over 18 with liver tumors that cannot be surgically removed and can consent to treatment.I am eligible for Y90 treatment, can perform daily activities, expected to live 3+ months, and not pregnant or using contraception if premenopausal.
Research Study Groups:
This trial has the following groups:- Group 1: TriSalus™ TriNav™Infusion System (catheter)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies available for potential participants in this research?
"Clinicaltrials.gov states that this medical research project is no longer enrolling patients, as the most recent iteration of the trial was edited on February 15th 2023. However, 256 other trials are still actively seeking participants at present."
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