Pressure-enabled Delivery in Radioembolization (TriNav Study)
PEDIR
A Prospective, Randomized, Open-Label Study to Examine The Effects of a Pressure-Enabled Drug Delivery Device on Radiotracer Distribution Compared to a Standard Microcatheter in the Context of Radioembolization
1 other identifier
interventional
20
1 country
2
Brief Summary
The purpose of the study is to determine if the type of catheter used in the mapping procedure prior to radioembolization improves the delivery of radioactivity to tumor(s) in participants with liver cancer. The name of the devices involved in this study are:
- Pressure Enabled Drug Delivery (PEDD)/TriNav Infusion System
- Standard 2.4F microcatheter, not otherwise specified
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2021
CompletedFirst Posted
Study publicly available on registry
November 19, 2021
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
March 19, 2026
October 1, 2025
4.3 years
November 9, 2021
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiotracer distribution
The primary endpoint of the study is radiotracer distribution, as measured by tumor to normal liver (T:N) ratio. Using SPECT/CT images collected subsequent to radiotracer delivery in mapping procedures, the volumetric tumor to normal liver (T:N) ratio of 99mTc-MAA distribution will be calculated using advanced imaging processing software, such as MIM SurePlan MRT. The T:N ratio of 99mTc-MAA delivered via the standard microcatheter will be compared to the PEDD device for each patient. The T:N ratio will be calculated for each tumor as well as in aggregate for the three largest tumors as described in Section 12.
Up to 2 years
Secondary Outcomes (2)
Mapping procedure comparison of Tumor to Normal (T:N) ratio between standard microcatheter and pressure-enabled delivery catheter
Up to 2 years
Technical success of radiotracer delivery as measured by ability to deliver radiotracer
Up to 2 years
Study Arms (2)
Sequence A: Standard microcatheter for Mapping #1 and PEDD device for Mapping #2.
EXPERIMENTALParticipants with either hepatocellular carcinoma (HCC) or colorectal liver metastases tumors receiving standard of care radioembolization treatment will be randomly assigned to undergo a routine mapping procedure first using a standard microcatheter 2-21 days before their radioembolization treatment day. Then on day of radioembolization treatment, an extra mapping procedure using the PEDD device catheter will be done just prior to the treatment.
Sequence B: PEDD device for Mapping #1 and standard microcatheter for Mapping #2.
EXPERIMENTALParticipants with either hepatocellular carcinoma (HCC) or colorectal liver metastases tumors receiving standard of care radioembolization treatment will be randomly assigned to undergo a routine mapping procedure first using the PEDD device catheter 2-21 days before their radioembolization treatment day. Then on day of radioembolization treatment, an extra mapping procedure using a standard microcatheter will be done just prior to the treatment.
Interventions
Small device used for mapping as part of radioembolization procedure
Pressure enabled small device used for mapping as part of radioembolization procedure
Eligibility Criteria
You may qualify if:
- Known HCC or CLM that are not amenable to curative resection or thermal ablative techniques such as microwave ablation.
- Prior clinical decision for treatment by radioembolization.
- Disease that is visible on CT or MRI as well as measurable disease in the liver. Measurable is defined as at least one lesion in the expected treatment field that can be accurately measured in at least one dimension (longest diameter) as (≥1 cm) with CT scan or MRI.
- Age ≥18 years. Because there is limited data with respect to radioembolization in patients \<18 years of age with respect to tumor dosimetry and associated adverse events participants \<18 years of age, children are excluded from this study.
- ECOG performance status \< 2 (Karnofsky ≥60%, see Appendix A).
- Life expectancy \>16 weeks.
- Suitable target artery diameter(s), defined in the TriNav labelling as 1.5 to 3.5mm vessels, based upon pre-procedural imaging.
- Adequate organ and marrow function as defined below:
- International Normalized Ratio (INR): ≤ 1.5
- Hemoglobin: ≥ 8.5 g/dL
- Leukocytes: ≥2,000/mcL
- Absolute neutrophil count: ≥1,00/mcL
- Platelets: ≥50,000/mcL(after transfusion, if necessary)
- Total bilirubin: ≤2.0 mg/dL
- Albumin: ≥3 g/dL
- +7 more criteria
You may not qualify if:
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
- Unresolved toxicities related to cancer therapy that the investigator will continue and compromise patient safety.
- History of hepatic encephalopathy; history of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be managed medically.
- Uncontrolled intercurrent illness.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Prior external beam radiation treatment to the liver or prior intra-arterial liver-directed therapy including transarterial bland embolization, chemoembolization or radioembolization.
- Contraindications to angiography and selective visceral catheterization, including bleeding diathesis or uncorrectable coagulopathy.
- \> 50% of tumor involvement of the liver.
- Receipt of intervention for the Ampulla of Vater or compromise thereof.
- Child-Pugh B8 or greater.
- Evidence of thrombosis in the main portal vein.
- For CLM patients: evidence of cirrhosis or portal hypertension.
- For CLM: Clinically-evident ascites other than trace noted on imaging.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TriSalus Life Sciences, Inc.collaborator
- Massachusetts General Hospitallead
Study Sites (2)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02245, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick D Sutphin, MD, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 9, 2021
First Posted
November 19, 2021
Study Start
March 1, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
March 19, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.