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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 : March 1, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Tracking Information
First Submitted Date  ICMJE June 22, 2017
First Posted Date  ICMJE June 26, 2017
Last Update Posted Date March 1, 2021
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date July 12, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2021)
  • Treatment response to yttrium Y-90 radioembolization [ Time Frame: Up to 4 months ]
    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 [ 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2017)
  • 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
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer
Official Title  ICMJE Ultrasound Microbubble Destruction and Perfusion Quantification for Improving Radioembolization Therapy of Hepatocellular Carcinoma
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hepatocellular Carcinoma
Intervention  ICMJE
  • Procedure: Yttrium-90 Microsphere Radioembolization
    Undergo standard of care Y-90 radioembolization
    Other Names:
    • Yttrium Y 90 Microsphere Therapy
    • Yttrium-90 Radioembolization
  • Drug: Perflutren Protein-Type A Microspheres
    Given IV.
    Other Name: Optison
  • Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging
    Undergo CEUS
Study Arms  ICMJE
  • 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 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.
    Interventions:
    • Procedure: Yttrium-90 Microsphere Radioembolization
    • Drug: Perflutren Protein-Type A Microspheres
    • Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging
  • Active Comparator: Group II (standard of care)
    Patients undergo standard of care yttrium Y-90 radioembolization.
    Intervention: Procedure: Yttrium-90 Microsphere Radioembolization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2019)
104
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2017)
52
Estimated Study Completion Date  ICMJE December 29, 2023
Estimated Primary Completion Date July 12, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: John Eisenbrey, PhD (215) 503-5188 john.eisenbrey@jefferson.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03199274
Other Study ID Numbers  ICMJE 17F.222
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )
Study Sponsor  ICMJE Sidney Kimmel Cancer Center at Thomas Jefferson University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: John Eisenbrey, PhD Sidney Kimmel Cancer Center at Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP