Liver CancerPhase 4NCT02853500
Effect of Surefire Infusion Device on Tumor Response to Regional Intra-arterial Therapy for Primary Liver Malignancies
A Phase 4 study testing TriNav, Traditional Delivery and Doxorubicin in people with Liver Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is studying the TriNav ("TriSalus") for increasing delivery of chemotherapeutic agents delivered trans-arterially to intermediate stage Hepatocellular Carcinoma ("HCC") (Barcelona Clinic Liver Cancer (BCLC) class B; locally advanced, liver restricted disease patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- TriNav, Traditional Delivery and Doxorubicin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 3 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable HCC, defined by imaging criteria or cytohistologic assessment. TACE as a preferred method of treatment is determined by a multidisciplinary Brigham and Women's Hospital / Dana Farber Cancer Institute (BWH/DFCI) Liver Tumor Board.
- Intermediate stage HCC (BCLC class B), not eligible for curative treatment, but with Child-Pugh A or B. Additionally, tumor cannot involve greater than 50% of the entire liver.
- Prior systemic chemotherapy is allowable.
- Age 18-75 years. The pediatrics population is not included as this disease has very low prevalence in that population.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Life expectancy of greater than at least 12 months.
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- Participants must have normal organ and marrow function as defined below:
- leukocytes ≥3,000/mcL
- absolute neutrophil count ≥1,500/mcL
- platelets ≥60,000/mcL
- total bilirubin within normal institutional limits
- Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) ≤2.5 × institutional upper limit of normal
- creatinine within normal institutional limits or,
- creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- No previous regional treatment (includes surgery, radiation or liver-directed arterial or ablative therapy).
- Main tumor size > 1 cm
- The effects of the study arm on the developing human fetus are unknown, however they are no different than for those in the control group. In addition, because significant radiation will be delivered during the procedure, a positive pregnancy test will exclude patients from the study in addition to excluding them from receiving standard therapy.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who have had prior local regional therapy including radiation therapy, trans-arterial therapy, or ablative therapy.
- A hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the non-tumorous liver parenchyma on arterial phase computed tomography scans).
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy.
- Severe underlying cardiac or renal diseases.
- Color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice.
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- 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.
- Human Immunodeficiency Virus (HIV)-positive patients are NOT excluded from the study.
- Patients who cannot undergo MRI evaluation/examination (eg. pacemaker or other metallic implant)
- History of allergic reactions attributed to agents used in study (i.e. doxorubicin, epirubicin, MRI contrast agents or iodinated contrast agents).
- Pregnant women are excluded from this study because the chemotherapy utilized within the chemoembolic agent is teratogenic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemoembolic agent, breastfeeding should be discontinued if the mother is treated with chemoembolic agent. These potential risks may also apply to other agents used in this study as well as from the radiation associated with the angiographic procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
This research study is studying the TriNav ("TriSalus") for increasing delivery of chemotherapeutic agents delivered trans-arterially to intermediate stage Hepatocellular Carcinoma ("HCC") (Barcelona Clinic Liver Cancer (BCLC) class B; locally advanced, liver restricted disease patients.
The names of the study interventions involved in this study are:
-Trans-arterial chemoembolization ("TACE") with or without the utilization of Surefire
Read the detailed description
This research study is a randomized Pilot study, which is the first time investigators are examining use of the TriNav device to improve tumor perfusion. Specifically, this study compares TACE both with or without the use of the TriNav device
Investigators are doing this research to determine if a TriNav Infusion System can improve tumor response to liver-directed intra-arterial chemotherapy compared to a traditional microcatheter.
TriNav is a Food and Drug Administration-approved valve-like device that blocks backflow within the artery but also generates increased pressure in a tumor feeder vessel during infusion. During this study, participants will receive the same medication in the same dose and the same way it would be delivered to the liver as a standard of care procedure, only either through a regular microcatheter (which is the standard of care procedure) or a TriNav Infusion System (which is a modified microcatheter).
- Conditions
- Liver Cancer
- Being tested
- TriNav, Traditional Delivery, Doxorubicin
- Keywords
- Liver Cancer
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriNavDevice
TriNav is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.
Traditional DeliveryDevice
Low profile tubing microcatheter for easier access to more peripheral/distal vascular branches for precise targeted delivery of medications.
DoxorubicinDrug
Also called Adriamycin
Medication used in cancer chemotherapy, including intraarterial delivery for liver malignancies.
| Study group | Role | What they receive |
|---|---|---|
| TACE Procedure With TriNav | Experimental | Patients will receive a single administration of intra-arterial chemotherapy (Doxorubicin) during the TACE procedure via TriNav.
* Patients will undergo structural follow-up for a timeframe of one year post treatment
* Post-procedural, contrast-enhanced Magnetic Resonance Imaging (MRI) will be performed one month after trial entry, and at regular intervals thereafter for a total of one year to assess tumor response Receives: Device: TriNav; Drug: Doxorubicin |
| TACE Procedure Traditional Delivery | Active comparator | Patients will receive a single administration of intra-arterial chemotherapy (Doxorubicin) during the TACE procedure via Traditional Delivery.
* Patients will undergo structural follow-up for a timeframe of one year post treatment
* Post-procedural, contrast-enhanced Magnetic Resonance Imaging (MRI) will be performed one month after trial entry, and at regular intervals thereafter for a total of one year to assess tumor response Receives: Device: Traditional Delivery; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capillary permeability (Ktrans) calculated by software that analyzes enhancement on post-contrast MRI.
Ktrans represents a calculated metric that represents a measure of capillary permeability obtained during dynamic contrast enhanced MRI; it represents an absolute value of tracer concentration within the tissue of interest. It is calculated by measuring the accumulation of contrast agent on post-contrast MR images within a given tissue over time and comparing it to a baseline contrast-filled structure such as a blood vessel. The measurement represents accumulation of contrast for a given tissue, as determined by the investigator.
Normality of the distribution will be tested using Shapiro-Wilk test. To compare Ktrans, the investigators will apply t-test or Wilcoxon rank sum test as appropriate.
Measured: 2 years
Secondary outcomes (4)
Extravascular extracellular volume fraction (ve) calculated by software that analyzes enhancement on post-contrast MRI.
Calculation of this value allows for more detailed analysis of contrast-enhancement of the tissue of interest. It represents an absolute value of tracer concentration within the tissue of interest, similar to Ktrans.
Measured: 2 years
Rate constant (kep)
Calculation of this value allows for more detailed analysis of contrast-enhancement of the tissue of interest. It represents a derived value (kep = ktrans/ve) and is dependent upon ktrans and ve.
Measured: 2 years
Plasma volume (vp) calculated by software that analyzes enhancement on post-contrast MRI.
Calculation of this value allows for more detailed analysis of contrast-enhancement of the tissue of interest. It represents an absolute value of tracer concentration within the plasma and allows for more accurate measurement of tissue permeability.
Measured: 2 years
Time To Tumor Progression
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
Why it stopped: No participants enrolled. Inability to perform intraprocedural MRI with the intraarterial infusion catheter in place due to MRI incompatibility.
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 Dana-Farber Cancer InstituteThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmitry Rabkin, MD, Dana-Farber Cancer Institute
- Investigators
- Dmitry Rabkin, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853500
- Sponsor's protocol ID
- 16-077
- Status last verified
- Feb 2025
- First submitted
- 30 Jun 2016
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Surefire Infusion Device on Tumor Response to Regional Intra-arterial Therapy for Primary Liver Malignancies
- ClinicalTrials.gov ID
- NCT02853500
- Acronym / sponsor ID
- 16-077
- Conditions
- Liver Cancer
- Keywords
- Liver Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled. Inability to perform intraprocedural MRI with the intraarterial infusion catheter in place due to MRI incompatibility.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 3 Aug 2016 (estimated)
- 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.
This research study is studying the TriNav ("TriSalus") for increasing delivery of chemotherapeutic agents delivered trans-arterially to intermediate stage Hepatocellular Carcinoma ("HCC") (Barcelona Clinic Liver Cancer (BCLC) class B; locally advanced, liver restricted disease patients.
The names of the study interventions involved in this study are:
-Trans-arterial chemoembolization ("TACE") with or without the utilization of Surefire
Detailed description
This research study is a randomized Pilot study, which is the first time investigators are examining use of the TriNav device to improve tumor perfusion. Specifically, this study compares TACE both with or without the use of the TriNav device
Investigators are doing this research to determine if a TriNav Infusion System can improve tumor response to liver-directed intra-arterial chemotherapy compared to a traditional microcatheter.
TriNav is a Food and Drug Administration-approved valve-like device that blocks backflow within the artery but also generates increased pressure in a tumor feeder vessel during infusion. During this study, participants will receive the same medication in the same dose and the same way it would be delivered to the liver as a standard of care procedure, only either through a regular microcatheter (which is the standard of care procedure) or a TriNav Infusion System (which is a modified microcatheter).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE Procedure With TriNav | Experimental | Device: TriNav, Drug: DoxorubicinPatients will receive a single administration of intra-arterial chemotherapy (Doxorubicin) during the TACE procedure via TriNav. * Patients will undergo structural follow-up for a timeframe of one year post treatment * Post-procedural, contrast-enhanced Magnetic Resonance Imaging (MRI) will be performed one month after trial entry, and at regular intervals thereafter for a total of one year to assess tumor response |
| TACE Procedure Traditional Delivery | Active comparator | Device: Traditional Delivery, Drug: DoxorubicinPatients will receive a single administration of intra-arterial chemotherapy (Doxorubicin) during the TACE procedure via Traditional Delivery. * Patients will undergo structural follow-up for a timeframe of one year post treatment * Post-procedural, contrast-enhanced Magnetic Resonance Imaging (MRI) will be performed one month after trial entry, and at regular intervals thereafter for a total of one year to assess tumor response |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Unresectable HCC, defined by imaging criteria or cytohistologic assessment. TACE as a preferred method of treatment is determined by a multidisciplinary Brigham and Women's Hospital / Dana Farber Cancer Institute (BWH/DFCI) Liver Tumor Board.
- Intermediate stage HCC (BCLC class B), not eligible for curative treatment, but with Child-Pugh A or B. Additionally, tumor cannot involve greater than 50% of the entire liver.
- Prior systemic chemotherapy is allowable.
- Age 18-75 years. The pediatrics population is not included as this disease has very low prevalence in that population.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Key exclusion criteria (11 listed)
- Participants who have had prior local regional therapy including radiation therapy, trans-arterial therapy, or ablative therapy.
- A hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the non-tumorous liver parenchyma on arterial phase computed tomography scans).
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy.
- Severe underlying cardiac or renal diseases.
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 |
|---|---|---|
| TriNavTriNav is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream. | Device | TACE Procedure With TriNav |
| Traditional DeliveryLow profile tubing microcatheter for easier access to more peripheral/distal vascular branches for precise targeted delivery of medications. | Device | TACE Procedure Traditional Delivery |
| DoxorubicinAlso: AdriamycinMedication used in cancer chemotherapy, including intraarterial delivery for liver malignancies. | Drug | TACE Procedure Traditional Delivery, TACE Procedure With TriNav |
Primary outcome
Capillary permeability (Ktrans) calculated by software that analyzes enhancement on post-contrast MRI.
Time frame: 2 years
Ktrans represents a calculated metric that represents a measure of capillary permeability obtained during dynamic contrast enhanced MRI; it represents an absolute value of tracer concentration within the tissue of interest. It is calculated by measuring the accumulation of contrast agent on post-contrast MR images within a given tissue over time and comparing it to a baseline contrast-filled structure such as a blood vessel. The measurement represents accumulation of contrast for a given tissue, as determined by the investigator. Normality of the distribution will be tested using Shapiro-Wilk test. To compare Ktrans, the investigators will apply t-test or Wilcoxon rank sum test as appropriate.
4 secondary outcomes
Extravascular extracellular volume fraction (ve) calculated by software that analyzes enhancement on post-contrast MRI.
Time frame: 2 years
Rate constant (kep)
Time frame: 2 years
Plasma volume (vp) calculated by software that analyzes enhancement on post-contrast MRI.
Time frame: 2 years
Time To Tumor Progression
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Dmitry Rabkin, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TriNav, Traditional Delivery and Doxorubicin in people with Liver Cancer, run by Dana-Farber Cancer Institute 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 18 inclusion and 11 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: withdrawn, as of the sponsor's last update on 5 Feb 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Capillary permeability (Ktrans) calculated by software that analyzes enhancement on post-contrast MRI. (time frame: 2 years). 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 5 Feb 2025.