Instylla HES Hypervascular Tumor Pivotal Study

NCT04523350 | Completed DMC FDA Device

• 1 other identifier: INY-P-20-001
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 15

Brief Summary

To determine whether Instylla HES has the ability to effectively embolize targeted arterial segments of hypervascular tumors as well as (i.e., is non-inferior to) standard of care (SOC) transarterial embolization/conventional transarterial chemoembolization, while resulting in an acceptable risk of device and procedure-related serious adverse events.

Conditions

Hypervascular Tumors

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint: Delivery of the embolic agent to the index tumor feeding vessel with stasis of flow as determined by an independent radiologist via comparison of the pre and final post procedure images

  Stasis of flow defined as absence of contrast flow within the targeted tumor feeding vessel

  Immediately post-embolization procedure

• Primary Safety Endpoint: Freedom from major adverse events through 30 days post-index procedure

  30 days post-embolization procedure

Study Arms (2)

Instylla HES

EXPERIMENTAL

Device: Instylla HES

Control

ACTIVE COMPARATOR

TAE or cTACE

Other: TAE or cTACE

Interventions

Instylla HES DEVICE

Instylla HES is a novel liquid embolic made of primarily water and polyethylene glycol (PEG)

Instylla HES

TAE or cTACE OTHER

Bland TAE or cTACE

Also known as: Control

Control

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects age ≥ 22 years old
• Subjects with confirmed finding of hypervascular tumor on CT and/or MRI for whom TAE or cTACE is medically indicated, including but not limited to:
• Subjects with unresectable primary or metastatic hepatic cancer
• Subjects with primary, metastatic or benign renal tumors
• Subjects with bone metastases
• Subjects with adrenal tumors
• Subjects with other hypervascular tumors
• Subjects with at least one target lesion that is well-delineated such that, in the Investigator's opinion, the lesion can be measured in at least one dimension as 1 cm or more, suitable for remeasurement, and demonstrating definitive arterial enhancement (Note: Pre-operative tumors do not need to meet this criterion.)
• Subjects with at least one target vessel ≤ 5mm and Instylla HES can be delivered to the target vessel(s).
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2 (PS 0-1 for metastatic disease)
• Subject or authorized representative have been informed of the nature of the study and has provided written informed consent approved by the appropriate local Ethics Committee/Institutional Review Board and agrees to comply with all protocol specified follow-up appointments.
• Expected life expectancy ≥ 6 months after Index embolization

You may not qualify if:

• Embolization for lesions other than hypervascular tumors such as arteriovenous malformations.
• It is anticipated that not all target vessels requiring embolization during the index procedure can be embolized with either HES alone or the SOC embolization agent as assigned.
• Undergoing radioembolization or DEB-TACE for Index Procedure
• Undergoing a planned secondary procedure the same day as the Index Procedure
• Requires TAE/cTACE for liver tumors via extrahepatic collateral artery(ies)
• Prior radioembolization of the target tumor lesion/vascular bed within 30 days of the Index Procedure.
• For subjects with HCC or undergoing embolization to the liver: Child-Pugh Class C or presence of complete portal vein thrombosis.
• Tumor lesions \> 8 cm in diameter (in one direction) or \>50% tumor volume burden of the target organ
• If subject was treated with Avastin, last dose is within 4 weeks of the planned procedure.
• Known severe atheromatosis or vascular anatomy that precludes catheterization
• Presence of bilioenteric anastomoses and/or prior biliary stenting/drainage or any violation of the biliary sphincter, including sphincterotomy for embolization of liver tumors
• Target lesion supplied by the pulmonary artery, coronary artery, or cerebral or cerebellar artery (requiring embolization of these arteries) or the artery to be embolized has connections to these arteries via a collateral pathway
• Known allergies (based on history) to PEG, ferrous compounds, tert Butyl Hydroperoxide, contrast media or procedural sedatives/anesthetics that is not amenable to pre-medication
• Uncorrectable impaired clotting: Platelet count \<30,000/µL or International Normalized Ratio (INR) \> 1.5
• Serum creatinine \> 2 mg/dL

Sponsors & Collaborators

• Instylla, Inc.: lead

Study Sites (15)

UAB Hospital

Birmingham, Alabama, 35233, United States

Location

Central Arkansas Radiation Therapy Institute, Inc.

Little Rock, Arkansas, 72205, United States

Location

University of California, Irvine

Irvine, California, 92697- 7600, United States

Location

Memorial Health Services

Long Beach, California, 92708, United States

Location

Olive View-UCLA Education & Research Institute

Sylmar, California, 91342-1495, United States

Location

St. Elizabeth Healthcare

Edgewood, Kentucky, 41017, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Summit Health

Florham Park, New Jersey, 07932, United States

Location

New York and Presbyterian Hospital (Cornell/Weill Medical College)

New York, New York, 10065, United States

Location

Charlotte Radiology

Charlotte, North Carolina, 28202, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6061, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai

Toronto, Ontario, M5G 1Z5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Study Officials

• Nadine Abi-Jaoudeh, M.D.

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 21, 2020
• Study Start: January 4, 2021
• Primary Completion: May 1, 2024
• Study Completion: November 19, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (12)