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Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer

Primary Purpose

Hepatocellular Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Yttrium-90 Microsphere Radioembolization
Perflutren Protein-Type A Microspheres
Dynamic Contrast-Enhanced Ultrasound Imaging
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be scheduled for sub-lobar radioembolization therapy of a previously untreated HCC mass < 6 cm visible on grayscale ultrasound
  • Be medically stable
  • If a female of child-bearing age, have a negative pregnancy test prior to each ultrasound exam
  • Have signed informed consent to participate in the study

Exclusion Criteria:

  • Females who are pregnant or nursing

  • Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:

    • Patients on life support or in a critical care unit
    • Patients with unstable occlusive disease (e.g., crescendo angina)
    • Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
    • Patients with uncontrolled congestive heart failure (New York heart Association [NYHA] class IV)
  • Patients with recent cerebral hemorrhage
  • Patients with known sensitivities to albumin, blood, or blood products
  • Patients with known hypersensitivity to perflutren
  • Patients with known cardiac shunts
  • Patients with known congenital heart defects
  • Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary embolism
  • Patients with respiratory distress syndrome
  • Patients with a history of bleeding disorders
  • Patients with bilirubin levels > 2 mg/dL

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (perflutren protein-type A microspheres, CEUS)

Group II (standard of care)

Arm Description

Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo CEUS over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.

Patients undergo standard of care yttrium Y-90 radioembolization.

Outcomes

Primary Outcome Measures

Treatment response to yttrium Y-90 radioembolization
Measured using the modified Response Evaluation Criteria in Solid Tumors. Will be tested with a non-parametric Mann- Whitney U-test of the difference in response distributions between control (radioembolization alone) and experimental group (ultrasound-triggered microbubble destruction [UTMD] + radioembolization). The outcome variable in this analysis, the modified Response Evaluation Criteria in Solid Tumors (mRECIST) score, is treated as an ordinal variable in this analysis.
Tumor perfusion measured by contrast-enhanced ultrasound between ultrasound-triggered microbubble destruction pulses
Perfusion will be characterized in terms of contrast replenishment time intensity curves fit with a 2-parameter exponential recovery curve. The relationship between the normalized perfusion values from this image processing and the patients' subsequent mRECIST scores in the UTMD + radioembolization group will be evaluated with Spearman's rank order correlation.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2017
Last Updated
November 16, 2022
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03199274
Brief Title
Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer
Official Title
Ultrasound Microbubble Destruction and Perfusion Quantification for Improving Radioembolization Therapy of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 12, 2023 (Anticipated)
Study Completion Date
December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This phase II trial studies how well perflutren protein-type A microspheres and contrast-enhanced ultrasound work in improving response to radioembolization therapy in patients with liver cancer. Ultrasound contrast agents, such as perflutren protein-type A microspheres, use gas microbubbles to improve image quality. Using contrast-enhanced ultrasound imaging will "pop" these microbubbles and cause tumors to become more sensitive to radiation therapies.
Detailed Description
PRIMARY OBJECTIVE: I. Characterize the ability of localized ultrasound contrast agent destruction to improve hepatocellular carcinoma (HCC) response to yttrium Y-90 (Y90) radioembolization. SECONDARY OBJECTIVE: I. Determine if contrast-enhanced ultrasound estimated tumor perfusion can reliably predict HCC response to radioembolization 1-14 days post treatment. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive perflutren protein-type A microspheres intravenously (IV) over 10 minutes and undergo contrast-enhanced ultrasound (CEUS) over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization. GROUP II: Patients undergo standard of care yttrium Y-90 radioembolization. After completion of study treatment, patients are followed up at 1 month and at 3-4 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (perflutren protein-type A microspheres, CEUS)
Arm Type
Experimental
Arm Description
Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo CEUS over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.
Arm Title
Group II (standard of care)
Arm Type
Active Comparator
Arm Description
Patients undergo standard of care yttrium Y-90 radioembolization.
Intervention Type
Procedure
Intervention Name(s)
Yttrium-90 Microsphere Radioembolization
Other Intervention Name(s)
Yttrium Y 90 Microsphere Therapy, Yttrium-90 Radioembolization
Intervention Description
Undergo standard of care Y-90 radioembolization
Intervention Type
Drug
Intervention Name(s)
Perflutren Protein-Type A Microspheres
Other Intervention Name(s)
Optison
Intervention Description
Given IV.
Intervention Type
Procedure
Intervention Name(s)
Dynamic Contrast-Enhanced Ultrasound Imaging
Intervention Description
Undergo CEUS
Primary Outcome Measure Information:
Title
Treatment response to yttrium Y-90 radioembolization
Description
Measured using the modified Response Evaluation Criteria in Solid Tumors. Will be tested with a non-parametric Mann- Whitney U-test of the difference in response distributions between control (radioembolization alone) and experimental group (ultrasound-triggered microbubble destruction [UTMD] + radioembolization). The outcome variable in this analysis, the modified Response Evaluation Criteria in Solid Tumors (mRECIST) score, is treated as an ordinal variable in this analysis.
Time Frame
Up to 4 months
Title
Tumor perfusion measured by contrast-enhanced ultrasound between ultrasound-triggered microbubble destruction pulses
Description
Perfusion will be characterized in terms of contrast replenishment time intensity curves fit with a 2-parameter exponential recovery curve. The relationship between the normalized perfusion values from this image processing and the patients' subsequent mRECIST scores in the UTMD + radioembolization group will be evaluated with Spearman's rank order correlation.
Time Frame
Up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be scheduled for sub-lobar radioembolization therapy of a previously untreated HCC mass < 6 cm visible on grayscale ultrasound Be medically stable If a female of child-bearing age, have a negative pregnancy test prior to each ultrasound exam Have signed informed consent to participate in the study Exclusion Criteria: Females who are pregnant or nursing Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example: Patients on life support or in a critical care unit Patients with unstable occlusive disease (e.g., crescendo angina) Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia Patients with uncontrolled congestive heart failure (New York heart Association [NYHA] class IV) Patients with recent cerebral hemorrhage Patients with known sensitivities to albumin, blood, or blood products Patients with known hypersensitivity to perflutren Patients with known cardiac shunts Patients with known congenital heart defects Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary embolism Patients with respiratory distress syndrome Patients with a history of bleeding disorders Patients with bilirubin levels > 2 mg/dL
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Eisenbrey, PhD
Phone
(215) 503-5188
Email
john.eisenbrey@jefferson.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Eisenbrey, PhD
Organizational Affiliation
Sidney Kimmel Cancer Center at Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Eisenbrey, MD
Email
john.eisenbrey@jefferson.edu

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer

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