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

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ClinicalTrials.gov Identifier: NCT03199274
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief Summary:
This randomized pilot clinical 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: Yttrium-90 Microsphere Radioembolization Drug: Perflutren Protein-Type A Microspheres Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. Characterize the ability of localized ultrasound contrast agent destruction to improve hepatocellular carcinoma (HCC) response to yttrium Y-90 (Y90) radioembolization.

II. Determine if contrast-enhanced ultrasound estimated tumor perfusion can reliably predict HCC response to radioembolization 1-14 days post treatment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound Microbubble Destruction and Perfusion Quantification for Improving Radioembolization Therapy of Hepatocellular Carcinoma
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 12, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Group I (perflutren protein-type A microspheres, CEUS)
Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo CEUS over 60 minutes at 2-6 hours and at 7 and 14 days after yttrium Y-90 radioembolization.
Procedure: Yttrium-90 Microsphere Radioembolization
Undergo standard of care Y-90 radioembolization
Other Name: Yttrium Y 90 Microsphere Therapy

Drug: Perflutren Protein-Type A Microspheres
Given IV
Other Name: Optison

Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging
Undergo CEUS

Active Comparator: Group II (standard of care)
Patients undergo standard of care yttrium Y-90 radioembolization.
Procedure: Yttrium-90 Microsphere Radioembolization
Undergo standard of care Y-90 radioembolization
Other Name: Yttrium Y 90 Microsphere Therapy




Primary Outcome Measures :
  1. Treatment response to yttrium Y-90 radioembolization measured using the modified Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 4 months ]
    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

  2. Tumor perfusion measured by contrast-enhanced ultrasound between ultrasound-triggered microbubble destruction pulses [ Time Frame: Up to 14 days ]

    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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 emboli
  • Patients with respiratory distress syndrome
  • Patients with a history of bleeding disorders
  • Patients with portal vein thrombus
  • Patients with bilirubin levels > 2 mg/dL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199274


Contacts
Contact: John Eisenbrey, PhD (215) 503-5188 john.eisenbrey@jefferson.edu

Locations
United States, Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: John Eisenbrey, MD       john.eisenbrey@jefferson.edu   
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
National Cancer Institute (NCI)
Investigators
Principal Investigator: John Eisenbrey, PhD Sidney Kimmel Cancer Center at Thomas Jefferson University

Additional Information:
Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03199274     History of Changes
Other Study ID Numbers: 17F.222
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases