Liver MetastasesNCT07791446
End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.
A study testing The TriNav Infusion Systems and Standard End Hole Microcatheter in people with Liver Metastases and Tumor, run by Stanford University at 1 site in United States.
Trial summary
Patients with liver metastases undergoing planning arteriography for Y-90 administration by interventional radiology will be screened for study enrollment. If there are at least 2 planned delivery sites with the same target mean dose to tumor and at least 1 tumor in each angiosome that is measurable by RECIST… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastases, Tumor
- What is being tested?
- The TriNav Infusion Systems and Standard End Hole Microcatheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2029
- 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
- Presence of multiple liver metastases
- Prior multidisciplinary clinical decision for treatment with radioembolization
- 18 years of age or older
- ECOG less than or equal to 2
- Life expectancy > 3 months
- Ability to understand and the willingness to provide written informed consent.
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- At least 2 planned Y-90 delivery sites/vessels with the same target mean dose to tumor
- Angiosome for each delivery site has at least 1 measurable tumor per RECIST criteria
- At least 1 target tumor per delivery site is exclusively supplied by the angiosome of the delivery site.
- Vascular anatomy suitable for use with the TriNav Infusion System, including target vessel diameter 1.5-5 mm.
- The vessel level for each planned delivery site is no further distal than the segmental level.
Who cannot join
- Pregnant
- Breast-feeding
- Lung shunt fraction > 20% or calculated lung dose > 30 Gy
- Prior hepatic transarterial embolization in the hepatic lobe to be treated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
David Marcellus contact
United States1 site
Stanford University
Palo Alto, California, 94305
Brittney G Worley, 650-736-3688, bw718@stanford.edu
David G Marcellus, MD, dmarcel2@stanford.edu
About this study
Official title: Pressure-Enabled Selective SIR-Sphere Uptake for Radiation Efficacy (PRESSURE): A Prospective Randomized Clinical Trial of End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.
Patients with liver metastases undergoing planning arteriography for Y-90 administration by interventional radiology will be screened for study enrollment. If there are at least 2 planned delivery sites with the same target mean dose to tumor and at least 1 tumor in each angiosome that is measurable by RECIST criteria, the patient is potentially eligible for this study (see full inclusion and exclusion criteria). On the day of Y-90 administration, one delivery site will be randomized to a standard end hole microcatheter while the other delivery site will be assigned to the TriNav Infusion System.
A standard of care post-Y-90 PET/CT will be performed and dosimetry analysis will be conducted. The patient will also undergo a standard of care MRI 3 months and 6 months following Y-90 administration and disease response will be graded according to RECIST/mRECIST criteria.
- Conditions
- Liver Metastases, Tumor
- Being tested
- The TriNav Infusion Systems, Standard End Hole Microcatheter
- Keywords
- Y-90, The TriNav Infusion Systems
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The TriNav Infusion SystemsDevice
The Y-90 dose to be delivered by the TriNav Infusion System will be determined and recorded by the Investigator or Sub-Investigator, calculated using partition-based dosimetry software (i.e. MIM SurePlan or Simplicit90y)
Standard End Hole MicrocatheterDevice
The comparator is a standard end hole microcatheter, defined as any commercially available microcatheter utilizing a single end hole without balloon occlusion or other tip modifications. The Y-90 dose delivered by the standard end hole microcatheter will be determined and recorded by the Investigator or Sub-Investigator and calculated using partition-based dosimetry software (e.g., MIM SurePlan or Simplicit90Y).
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | Participants undergo Y-90 administration using both the TriNav Infusion System and a standard end hole microcatheter, with delivery sites randomized within the participant. Receives: Device: The TriNav Infusion Systems; Device: Standard End Hole Microcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Absorbed Dose (Gy)
Tumor absorbed dose (Gy) measured using post-radioembolization ^90Y PET/CT and Simplicit90Y dosimetry analysis software. The endpoint will compare the absorbed dose delivered to tumors following Y-90 administration using the TriNav Infusion System versus a standard end-hole microcatheter.
Measured: Within 1 day following intervention
Secondary outcomes (4)
Tumor-to-Normal Liver Ratio (T/N Ratio)
T/N ratio measured on post-radioembolization ^90Y PET/CT using Simplicit90Y dosimetry analysis software. This endpoint evaluates preferential microsphere deposition within tumor relative to normal liver tissue and compares results between treatment groups.
Measured: Within 1 day following intervention
Objective Response Rate (ORR) by RECIST 1.1
Proportion of target lesions achieving complete response (CR) or partial response (PR) according to RECIST 1.1 criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.
Measured: 3 months and 6 months after radioembolization
Disease Control Rate (DCR) by RECIST 1.1
Proportion of target lesions achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST 1.1 criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.
Measured: 3 months and 6 months after radioembolization
Tumor Response by mRECIST for enhancing tumors
For tumors demonstrating arterial enhancement on pre-treatment imaging, treatment response will be assessed using mRECIST criteria on contrast-enhanced MRI of the abdomen at 3 and 6 months following radioembolization.
Measured: 3 months and 6 months after radioembolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver MetastasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Randomization occurs at the Y-90 delivery site level within participants, not between participant groups.
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- TriSalus Life Sciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Matthew Hung, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791446
- Sponsor's protocol ID
- IRB-88560
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure-Enabled Selective SIR-Sphere Uptake for Radiation Efficacy (PRESSURE): A Prospective Randomized Clinical Trial of End Hole vs. Pressure-Modulated Delivery of Y-90 Resin Microspheres to Liver Metastases.
- ClinicalTrials.gov ID
- NCT07791446
- Acronym / sponsor ID
- IRB-88560
- Conditions
- Liver Metastases, Tumor
- Keywords
- Y-90, The TriNav Infusion Systems
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- TriSalus Life Sciences, Inc.
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 28 Aug 2026 (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.
Patients with liver metastases undergoing planning arteriography for Y-90 administration by interventional radiology will be screened for study enrollment. If there are at least 2 planned delivery sites with the same target mean dose to tumor and at least 1 tumor in each angiosome that is measurable by RECIST criteria, the patient is potentially eligible for this study (see full inclusion and exclusion criteria). On the day of Y-90 administration, one delivery site will be randomized to a standard end hole microcatheter while the other delivery site will be assigned to the TriNav Infusion System.
A standard of care post-Y-90 PET/CT will be performed and dosimetry analysis will be conducted. The patient will also undergo a standard of care MRI 3 months and 6 months following Y-90 administration and disease response will be graded according to RECIST/mRECIST criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Randomization occurs at the Y-90 delivery site level within participants, not between participant groups.
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Device: The TriNav Infusion Systems, Device: Standard End Hole MicrocatheterParticipants undergo Y-90 administration using both the TriNav Infusion System and a standard end hole microcatheter, with delivery sites randomized within the participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Presence of multiple liver metastases
- Prior multidisciplinary clinical decision for treatment with radioembolization
- 18 years of age or older
- ECOG less than or equal to 2
- Life expectancy > 3 months
Key exclusion criteria (4 listed)
- Pregnant
- Breast-feeding
- Lung shunt fraction > 20% or calculated lung dose > 30 Gy
- Prior hepatic transarterial embolization in the hepatic lobe to be treated
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 |
|---|---|---|
| The TriNav Infusion SystemsThe Y-90 dose to be delivered by the TriNav Infusion System will be determined and recorded by the Investigator or Sub-Investigator, calculated using partition-based dosimetry software (i.e. MIM SurePlan or Simplicit90y) | Device | Single Group |
| Standard End Hole MicrocatheterThe comparator is a standard end hole microcatheter, defined as any commercially available microcatheter utilizing a single end hole without balloon occlusion or other tip modifications. The Y-90 dose delivered by the standard end hole microcatheter will be determined and recorded by the Investigator or Sub-Investigator and calculated using partition-based dosimetry software (e.g., MIM SurePlan or Simplicit90Y). | Device | Single Group |
Primary outcome
Tumor Absorbed Dose (Gy)
Time frame: Within 1 day following intervention
Tumor absorbed dose (Gy) measured using post-radioembolization ^90Y PET/CT and Simplicit90Y dosimetry analysis software. The endpoint will compare the absorbed dose delivered to tumors following Y-90 administration using the TriNav Infusion System versus a standard end-hole microcatheter.
4 secondary outcomes
Tumor-to-Normal Liver Ratio (T/N Ratio)
Time frame: Within 1 day following intervention
Objective Response Rate (ORR) by RECIST 1.1
Time frame: 3 months and 6 months after radioembolization
Disease Control Rate (DCR) by RECIST 1.1
Time frame: 3 months and 6 months after radioembolization
Tumor Response by mRECIST for enhancing tumors
Time frame: 3 months and 6 months after radioembolization
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 28 Aug 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.
David Marcellus contact
Matthew Hung, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The TriNav Infusion Systems and Standard End Hole Microcatheter in people with Liver Metastases and Tumor, run by Stanford University 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 11 inclusion and 4 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: opening soon, as of the sponsor's last update on 28 Aug 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?
Contact Brittney Worley (650-736-3688, bw718@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Absorbed Dose (Gy) (time frame: Within 1 day following intervention). 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 28 Aug 2026.