Effect of Surefire Infusion Device on Tumor Response to Regional Intra-arterial Therapy for Primary Liver Malignancies

NCT02853500 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 16-077
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. The names of the study interventions involved in this study are:

• Trans-arterial chemoembolization ("TACE") with or without the utilization of Surefire

Conditions

Liver Cancer

Keywords

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (4)

• Extravascular extracellular volume fraction (ve) calculated by software that analyzes enhancement on post-contrast MRI.

  2 years

• Rate constant (kep)

  2 years

• Plasma volume (vp) calculated by software that analyzes enhancement on post-contrast MRI.

  2 years

• Time To Tumor Progression

  2 years

Study Arms (2)

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

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

Device: Traditional Delivery; Drug: Doxorubicin

Interventions

TriNav DEVICE

TriNav is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.

TACE Procedure With TriNav

Traditional Delivery DEVICE

Low profile tubing microcatheter for easier access to more peripheral/distal vascular branches for precise targeted delivery of medications.

TACE Procedure Traditional Delivery

Doxorubicin DRUG

Medication used in cancer chemotherapy, including intraarterial delivery for liver malignancies.

Also known as: Adriamycin

TACE Procedure Traditional Delivery; TACE Procedure With TriNav

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Dmitry Rabkin, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: August 3, 2016
• Study Start: July 1, 2016
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)