Liver Cancer, Liver Tumor, Hepatocellular Carcinoma, Liver Carcinoma
Conditions
Keywords
Liver cancer, Hepatocellular Carcinoma, Liver imaging, Stereotactic Ablative Radiotherapy, SABR
Brief 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.
Detailed 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.
Interventions
DIAGNOSTIC_TEST3D ultrasound
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Blood Perfusion (Blood Volume) | Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment. | 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. |
| Changes in Blood Perfusion (Mean Flow Velocity) | Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment. | 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. |
| Changes in Blood Perfusion (Relative Blood Flow) | Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3D Perfusion Ultrasound Patients undergo 3D ultrasound perfusion imaging with perflutren lipid microspheres | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | 3D Perfusion Ultrasound |
|---|---|
| Age, Customized 50-59 | 3 Participants |
| Age, Customized 60-69 | 2 Participants |
| Age, Customized 70-79 | 5 Participants |
| Age, Customized 80-89 | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 11 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
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.
Time frame: Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
Population: No cases were analyzed; analysis was not possible due to poor image quality.
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.
Time frame: Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
Population: No cases were analyzed; analysis was not possible due to poor image quality.
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.
Time frame: Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
Population: No cases were analyzed; analysis was not possible due to poor image quality.