Hepatocellular CarcinomaTrinavNCT06204159
Lipiodol Deposition Using Endhole vs. Pressure-Modulated Delivery
A study testing TACE Catheters in people with Hepatocellular Carcinoma and Neuroendocrine Tumors, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
Trial summary
The goal of this clinical trial is to compare CT scan of the coverage of tumors treated with TACE using End Hole catheters to those treated with the TriNav catheter that alters tissue pressure. Both catheters are FDA approved for delivery of TACE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Neuroendocrine Tumors
- What is being tested?
- TACE Catheters
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged >18 years.
- Plan to undergo lipiodol TACE for HCC or NET liver metastases
- Bilobar disease or distribution for which staged therapy (more than one TACE) for distinct target tumors is planned
- Liver tumor burden does not exceed 50% of the liver volume
- Patent main portal vein
- Life expectancy of greater than 6 months
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- ECOG performance status 0-2
- Adequate liver function as measured by: Total bilirubin ≤ 2.0mg/dl, ALT, AST ≤5 times ULN, albumin ≥2.5g/dl
- Adequate marrow and renal function as defined as:
- Platelets >75,000/mcL (may be corrected by transfusion)
- Serum creatinine < 2.0 mg/dl
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such contraception from beginning of study treatment until 1 month following last TACE treatment, as recommended for TACE treatments not conducted within the trial.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner from first study treatment until 1 month following last TACE treatment.
- Provision of signed and dated informed consent form and ability to consent for oneself.
- Stated willingness to comply with all study procedures and availability for the study duration.
Who cannot join
- Absolute contraindication to contrast-enhanced MRI
- Absolute contraindication to intravenous iodinated contrast, including history of previous severe contrast reaction or moderate reaction not mitigated by appropriate pre-medication
- Pregnancy or lactation
- Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pennsylvania, Department of Radiology, Interventional Radiology Division
Philadelphia, Pennsylvania, 19104
About this study
Official title: Lipiodol Deposition in Hypervascular Tumors: Endhole vs. Pressure-modulated Delivery
The goal of this clinical trial is to compare CT scan of the coverage of tumors treated with TACE using End Hole catheters to those treated with the TriNav catheter that alters tissue pressure. Both catheters are FDA approved for delivery of TACE.
- Is there a difference in CT appearance with delivery in the type of catheter used during the TACE procedure?
Participants will be asked to undergo a TACE procedure, a CT scan and review of their medical record to compare End Hole and TriNav catheters during TACE procedures.
Read the detailed description
Hepatocellular (HCC) and neuroendocrine (NET) liver metastases undergoing Lipiodol transarterial chemoembolization (TACE) will be randomized to endhole vs. pressure-modulated catheter delivery. Lipiodol deposition will be quantified and correlated with volumetric necrosis, response, and local progression.
- Conditions
- Hepatocellular Carcinoma, Neuroendocrine Tumors
- Being tested
- TACE Catheters
- Keywords
- TACE, Catheter
- Medical subject headings
- Carcinoma, Hepatocellular, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE CathetersDevice
End Hole and TriNav catheters are FDA approved. This study is comparing the two for chemotherapy delivery during the TACE procedure.
This study will randomize which catheter is used for the first TACE procedure and the other catheter will be used for the second TACE procedure
| Study group | Role | What they receive |
|---|---|---|
| End Hole Catheter followed by TriNav Catheter | Experimental | FDA approved catheter
Randomization End Hole catheter then TriNav catheter Receives: Device: TACE Catheters |
| TriNav Catheter followed by End Hole Catheter | Experimental | FDA approved catheter
Randomization TriNav catheter then End Hold catheter Receives: Device: TACE Catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume and density of lipiodol
To estimate the relative volume and density of lipiodol deposition in hypervascular liver tumors
Measured: immediately following TACE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Feb 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Exploratory
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- TriSalus Life Sciences, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204159
- Sponsor's protocol ID
- UPCC 01223
- Other IDs
- 853163
- Acronym
- Trinav
- Status last verified
- Jun 2026
- First submitted
- 3 Jan 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipiodol Deposition in Hypervascular Tumors: Endhole vs. Pressure-modulated Delivery
- ClinicalTrials.gov ID
- NCT06204159
- Acronym / sponsor ID
- Trinav / UPCC 01223
- Conditions
- Hepatocellular Carcinoma, Neuroendocrine Tumors
- Keywords
- TACE, Catheter
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- TriSalus Life Sciences, Inc.
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare CT scan of the coverage of tumors treated with TACE using End Hole catheters to those treated with the TriNav catheter that alters tissue pressure. Both catheters are FDA approved for delivery of TACE.
- Is there a difference in CT appearance with delivery in the type of catheter used during the TACE procedure?
Participants will be asked to undergo a TACE procedure, a CT scan and review of their medical record to compare End Hole and TriNav catheters during TACE procedures.
Detailed description
Hepatocellular (HCC) and neuroendocrine (NET) liver metastases undergoing Lipiodol transarterial chemoembolization (TACE) will be randomized to endhole vs. pressure-modulated catheter delivery. Lipiodol deposition will be quantified and correlated with volumetric necrosis, response, and local progression.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Exploratory
| Arm | Type | Receives |
|---|---|---|
| End Hole Catheter followed by TriNav Catheter | Experimental | Device: TACE CathetersFDA approved catheter Randomization End Hole catheter then TriNav catheter |
| TriNav Catheter followed by End Hole Catheter | Experimental | Device: TACE CathetersFDA approved catheter Randomization TriNav catheter then End Hold catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female, aged >18 years.
- Plan to undergo lipiodol TACE for HCC or NET liver metastases
- Bilobar disease or distribution for which staged therapy (more than one TACE) for distinct target tumors is planned
- Liver tumor burden does not exceed 50% of the liver volume
- Patent main portal vein
Key exclusion criteria (5 listed)
- Absolute contraindication to contrast-enhanced MRI
- Absolute contraindication to intravenous iodinated contrast, including history of previous severe contrast reaction or moderate reaction not mitigated by appropriate pre-medication
- Pregnancy or lactation
- Choledochoenteric anastomosis, transpapillary stent or sphincterotomy of duodenal papilla
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACE CathetersEnd Hole and TriNav catheters are FDA approved. This study is comparing the two for chemotherapy delivery during the TACE procedure. This study will randomize which catheter is used for the first TACE procedure and the other catheter will be used for the second TACE procedure | Device | End Hole Catheter followed by TriNav Catheter, TriNav Catheter followed by End Hole Catheter |
Primary outcome
volume and density of lipiodol
Time frame: immediately following TACE
To estimate the relative volume and density of lipiodol deposition in hypervascular liver tumors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE Catheters in people with Hepatocellular Carcinoma and Neuroendocrine Tumors, run by Abramson Cancer Center at Penn Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume and density of lipiodol (time frame: immediately following TACE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.