Feasibility 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation

Hepatocellular Carcinoma Clinical Trial

Official title:

Feasibility of 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424955
• Other study ID #: IRB-30071
• Secondary ID: IRB-30071HEP0048
• Status: Completed
• Phase: N/A
• Start date: November 18, 2014
• Est. completion date: June 30, 2022

Study information

• Verified date: June 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.

Description:

Primary Objective:

The primary objectives of this prospective pilot study is to:

1. determine the feasibility and reproducibility of 3D contrast enhanced ultrasound imaging in liver cancer patients undergoing Stereotactic Ablative Radiotherapy and

2. evaluate whether there are treatment induced early changes in imaging metrics derived from 3D contrast enhanced ultrasound. This study will provide valuable insight as to the potential of baseline and/or early post-treatment 3D ultrasound perfusion characteristics (measurements of blood-flow) of primary and metastatic liver tumors to predict tumor response to Stereotactic Ablative Radiotherapy. The investigators' underlying goal is to assess whether early perfusion changes at 1-7 days after SABR initiation can be used as a non-invasive early biomarker for treatment response assessment.

Secondary Objectives:

Evaluate the feasibility of contrast-enhanced ultrasound-to-CT fusion by assisting three-dimensional (3D) perfusion ultrasound (US) imaging with optical and electromagnetic tracking of the ultrasound probe on patients with liver cancer that will undergo CT for treatment planning and/or response evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ability to understand and willingness to sign the written informed consent document

• Patient with primary liver tumor or metastasis scheduled for Stereotactic Ablative Radiotherapy (SABR)

• Patient is at least 18 years of age. No gender/race-ethnic restrictions.

• Performance status (ECOG) between 0-3

• History and Physical done within 4 weeks of enrollment.

Exclusion Criteria:

• Patient has previously been enrolled in and completed this study.

• Known right to left cardiac shunt, bidirectional or transient.

• Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.

• History of hypersensitivity to the contrast agent perflutren

• History of pulmonary hypertension

• Patients who are pregnant or are trying to become pregnant

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cancer
• Liver Carcinoma
• Liver Neoplasms
• Liver Tumor

Intervention

Drug:
• perflutren lipid microspheres

Diagnostic Test:
• 3D ultrasound

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Blood Perfusion (Blood Volume)	The purpose of this pilot project is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.	Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
Primary	Changes in Blood Perfusion (Mean Flow Velocity)	The purpose of this pilot project is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.	Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
Primary	Changes in Blood Perfusion (Relative Blood Flow)	The purpose of this pilot project is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.	Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.