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Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow Surrounding HAE

Primary Purpose

Hepatocellular Carcinoma, Liver Cancer

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lumason®

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Hepatic Artery Embolization, Liver Metastases, Radioembolization

Eligibility Criteria

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

Inclusion Criteria:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Men and women >18 years of age.
Histologically or cytologically confirmed hepatocellular carcinoma or meet imaging criteria for a diagnosis of hepatocellular carcinoma with tumor burden dominant in the liver.
Participants must have measurable disease, by CT or MRI per mRECIST, not be a candidate for surgical resection based on unresectability, anatomy, anesthesia risk, patient preference.
Serum Bilirubin ≤ 2.0
Platelet count > 50,000/ul (corrected if needed)
INR ≤ 1.5 (corrected if needed) 9. Serum creatinine < 2.0 mg/dl

Exclusion Criteria:

Participants must be at least one month beyond prior chemotherapy, ablation or surgery, and have recovered from all therapy-associated toxicities.
History of severe allergic reaction to intravenous contrast media (iodinated and gadoliniumbased) or any agents used during the embolization; participant cannot be medicated against allergic reaction prior to embolization or contrast enhanced ultrasound.
History of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason® microbubbles
Active infection
Participants with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias)
Pregnancy or lactation. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Participants may not be receiving any other investigational agents

Sites / Locations

Moffitt Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lumason Microbubbles

Arm Description

Participants will receive an IV administrative of Lumason® microbubbles, prior to radioembolization. 2 doses of 2.5mL will be administered

Outcomes

Primary Outcome Measures

Number of Participants with Early Tumor Response

Dynamic CEUS imaging will demonstrate perfusion characteristics that will predict early tumor response to Transarterial Y90 embolization in Hepatocellular Carcinoma. A change in intra-tumoral arterial flow will be predictive of early response. This will be evaluated immediately following hepatic artery embolization (day 0), at 4 weeks (follow-up 1), 12 weeks (follow-up 2) and 24 weeks (follow-up 3). A modified RECIST will be used to measure early tumor response.

Secondary Outcome Measures

Number of Participants with Early Signs of Radiation Induced Liver Disease (RILD)

Dynamic CEUS imaging will demonstrate perfusion characteristics that will predict early signs of Radiation Induced Liver Disease (RILD) after Transarterial Y90 embolization in Hepatocellular Carcinoma. This will be evaluated immediately following hepatic artery embolization (day 0), at 4 weeks (follow-up 1), 12 weeks (follow-up 2) and 24 weeks (follow-up 3).

Full Information

NCT ID

NCT04150874

First Posted

November 1, 2019

Last Updated

April 7, 2023

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04150874

Brief Title

Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow Surrounding HAE

Official Title

Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow and the Surrounding Hepatic Parenchyma Before, During and After Hepatic Artery Embolization

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Terminated

Why Stopped

Slow Accrual

Study Start Date

February 19, 2020 (Actual)

Primary Completion Date

May 14, 2021 (Actual)

Study Completion Date

May 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to find out if a study agent called Lumason® microbubbles may be helpful for people with lesions in the liver. It is possible it may help determine an early response to radioembolization and/or help demonstrate radiation toxicity to the surrounding liver.

6. Conditions and Keywords

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

Hepatocellular Carcinoma, Liver Cancer

Keywords

Hepatic Artery Embolization, Liver Metastases, Radioembolization

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lumason Microbubbles

Arm Type

Experimental

Arm Description

Participants will receive an IV administrative of Lumason® microbubbles, prior to radioembolization. 2 doses of 2.5mL will be administered

Intervention Type

Diagnostic Test

Intervention Name(s)

Lumason®

Intervention Description

Hepatic artery embolization using standard of care radioembolization and assessment of tumor and hepatic parenchymal perfusion kinetics before, during and after treatment with standard of care iodinated contrast (at the time of Y90 radioembolization treatment) and standard of care follow-up with multiphase CT or MRI with the addition of study agent Lumason microbubbles for contrast-enhanced ultrasound (which will be performed concurrently with standard evaluation).

Primary Outcome Measure Information:

Title

Number of Participants with Early Tumor Response

Description

Time Frame

Base line up to 24 weeks

Secondary Outcome Measure Information:

Title

Number of Participants with Early Signs of Radiation Induced Liver Disease (RILD)

Description

Time Frame

Base line up to 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Men and women >18 years of age. Histologically or cytologically confirmed hepatocellular carcinoma or meet imaging criteria for a diagnosis of hepatocellular carcinoma with tumor burden dominant in the liver. Participants must have measurable disease, by CT or MRI per mRECIST, not be a candidate for surgical resection based on unresectability, anatomy, anesthesia risk, patient preference. Serum Bilirubin ≤ 2.0 Platelet count > 50,000/ul (corrected if needed) INR ≤ 1.5 (corrected if needed) 9. Serum creatinine < 2.0 mg/dl Exclusion Criteria: Participants must be at least one month beyond prior chemotherapy, ablation or surgery, and have recovered from all therapy-associated toxicities. History of severe allergic reaction to intravenous contrast media (iodinated and gadoliniumbased) or any agents used during the embolization; participant cannot be medicated against allergic reaction prior to embolization or contrast enhanced ultrasound. History of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason® microbubbles Active infection Participants with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) Pregnancy or lactation. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Participants may not be receiving any other investigational agents

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melissa McGettigan, MD

Organizational Affiliation

Moffitt Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jennifer Sweeney, MD

Organizational Affiliation

Moffitt Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Contrast-Enhanced Ultrasound for the Evaluation of Changes in Tumor Blood Flow Surrounding HAE

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