Liver Metastases, Tumor
Conditions
Keywords
Y-90, The TriNav Infusion Systems
Brief 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 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.
Interventions
DEVICEThe TriNav Infusion Systems
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)
DEVICEStandard End Hole Microcatheter
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).
Sponsors
Stanford University
TriSalus Life Sciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomization occurs at the Y-90 delivery site level within participants, not between participant groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Presence of multiple liver metastases 2. Prior multidisciplinary clinical decision for treatment with radioembolization 3. 18 years of age or older 4. ECOG less than or equal to 2 5. Life expectancy \> 3 months 6. Ability to understand and the willingness to provide written informed consent. 7. At least 2 planned Y-90 delivery sites/vessels with the same target mean dose to tumor 8. Angiosome for each delivery site has at least 1 measurable tumor per RECIST criteria 9. At least 1 target tumor per delivery site is exclusively supplied by the angiosome of the delivery site. 10. Vascular anatomy suitable for use with the TriNav Infusion System, including target vessel diameter 1.5-5 mm. 11. The vessel level for each planned delivery site is no further distal than the segmental level.
Exclusion criteria
1. Pregnant 2. Breast-feeding 3. Lung shunt fraction \> 20% or calculated lung dose \> 30 Gy 4. Prior hepatic transarterial embolization in the hepatic lobe to be treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Absorbed Dose (Gy) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor-to-Normal Liver Ratio (T/N Ratio) | Within 1 day following intervention | 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. |
| Objective Response Rate (ORR) by RECIST 1.1 | 3 months and 6 months after radioembolization | 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. |
| Disease Control Rate (DCR) by RECIST 1.1 | 3 months and 6 months after radioembolization | 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. |
| Tumor Response by mRECIST for enhancing tumors | 3 months and 6 months after radioembolization | 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. |
Countries
United States
Contacts
CONTACTBrittney Worley
CONTACTDavid Marcellus
PRINCIPAL_INVESTIGATORMatthew Hung, MD
Stanford University
Outcome results
None listed