Clinical trial NCT03199274: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2017-06-26
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment response to yttrium Y-90 radioembolization
timeFrame: Up to 4 months
measure: Tumor perfusion measured by contrast-enhanced ultrasound between ultrasound-triggered microbubble destruction pulses
timeFrame: Up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Sidney Kimmel Cancer Center at Thomas Jefferson University
name: John Eisenbrey, PhD
role: PRINCIPAL_INVESTIGATOR
References: