Liver CancerNCT05743842
TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning
A study testing TriSalus™ TriNav™Infusion System, Angiogram and Y90-radioembolization procedure in people with Liver Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if using the 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- TriSalus™ TriNav™Infusion System, Angiogram and Y90-radioembolization procedure
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to 31 Dec 2027
- 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
- Patients over 18 years of age, of any race or sex, who have unresectable primary or metastatic tumors of the liver, and who are able to give informed consent.
- Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months, and must be non-pregnant with an acceptable contraception in premenopausal women.
- At least one lesion ≥ 3.0 cm in shortest dimension
- Negative pregnancy test in premenopausal women
Who cannot join
- Contraindications to angiography and selective visceral catheterization
- Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single injection.
- Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels)
- Infiltrative tumors
- Target vessel sizes outside of TriNav device prescribed diameter range of 1.5 - 3.5 mm
Trial locations and contacts
1 site in 1 country.
About this study
To learn if using the 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.
Read the detailed description
Primary Objectives:
To determine the percentage of tumors that demonstrate quantitative mean dose concordance (within 20%) using voxel-level quantitative SPECT/CT between 99mTc-MAA treatment planning to post therapy Y90 microspheres with an FDA-cleared Pressure Enabled Drug DeliveryTM (PEDDTM) device.
Secondary Objectives:
To determine the correlation of T:N ratios of all tumors 3cm based on 99mTc-MAA SPECT/CT and Y90 SPECT/CT imaging.
To determine the fidelity and concordance of perfused normal liver uptake and distribution between 99mTc-MAA treatment planning to post therapy Y90 microspheres SPECT/CT.
To assess safety of TriNav catheter in this study population
- Conditions
- Liver Cancer
- Being tested
- TriSalus™ TriNav™Infusion System, Angiogram, Y90-radioembolization procedure
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriSalus™ TriNav™Infusion SystemDevice
Given by Infusion
AngiogramDiagnostic test
X-ray photograph
Y90-radioembolization procedureProcedure or surgery
procedure
| Study group | Role | What they receive |
|---|---|---|
| TriSalus™ TriNav™Infusion System (catheter) | Experimental | 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 Receives: Device: TriSalus™ TriNav™Infusion System; Diagnostic Test: Angiogram; Procedure: Y90-radioembolization procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start14 Mar 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- TriSalus Life Sciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Armeen Mahvash, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743842
- Sponsor's protocol ID
- 2022-0769
- Other IDs
- NCI-2023-01620
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TriNav Infusion System for the Evaluation of Fidelity Between 99mTc-MAA and Y90-Microspheres Hepatic Distribution for Dosimetry Treatment Planning
- ClinicalTrials.gov ID
- NCT05743842
- Acronym / sponsor ID
- 2022-0769
- Conditions
- Liver Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- TriSalus Life Sciences, Inc.
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Feb 2023 (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.
To learn if using the 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.
Detailed description
Primary Objectives:
To determine the percentage of tumors that demonstrate quantitative mean dose concordance (within 20%) using voxel-level quantitative SPECT/CT between 99mTc-MAA treatment planning to post therapy Y90 microspheres with an FDA-cleared Pressure Enabled Drug DeliveryTM (PEDDTM) device.
Secondary Objectives:
To determine the correlation of T:N ratios of all tumors 3cm based on 99mTc-MAA SPECT/CT and Y90 SPECT/CT imaging.
To determine the fidelity and concordance of perfused normal liver uptake and distribution between 99mTc-MAA treatment planning to post therapy Y90 microspheres SPECT/CT.
To assess safety of TriNav catheter in this study population
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TriSalus™ TriNav™Infusion System (catheter) | Experimental | Device: TriSalus™ TriNav™Infusion System, Diagnostic Test: Angiogram, Procedure: Y90-radioembolization procedureTriNav 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years of age, of any race or sex, who have unresectable primary or metastatic tumors of the liver, and who are able to give informed consent.
- Patients must be eligible for Y90-radioembolization treatment, have an ECOG Performance Status score of ≤ 2, with a life expectancy of ≥ 3 months, and must be non-pregnant with an acceptable contraception in premenopausal women.
- At least one lesion ≥ 3.0 cm in shortest dimension
- Negative pregnancy test in premenopausal women
Key exclusion criteria (5 listed)
- Contraindications to angiography and selective visceral catheterization
- Evidence of potential delivery of greater than 30 Gy absorbed dose to the lungs with a single injection.
- Evidence of any detectable Tc-99m MAA flow to the stomach or duodenum, after application of established angiographic techniques to stop or mitigate such flow (eg, placing catheter distal to gastric vessels)
- Infiltrative tumors
- Target vessel sizes outside of TriNav device prescribed diameter range of 1.5 - 3.5 mm
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 |
|---|---|---|
| TriSalus™ TriNav™Infusion SystemGiven by Infusion | Device | TriSalus™ TriNav™Infusion System (catheter) |
| AngiogramX-ray photograph | Diagnostic test | TriSalus™ TriNav™Infusion System (catheter) |
| Y90-radioembolization procedureprocedure | Procedure or surgery | TriSalus™ TriNav™Infusion System (catheter) |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: Through study completion; an average of 1 year.
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 16 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Armeen Mahvash, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TriSalus™ TriNav™Infusion System, Angiogram and Y90-radioembolization procedure in people with Liver Cancer, run by M.D. Anderson Cancer Center at 1 site 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 4 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: Through study completion; an average of 1 year.). 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 16 Sep 2026.