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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-30071 | Other Identifier | Stanford IRB | |
| HEP0048 | Other Identifier | OnCore |
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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.
Primary Objective:
The primary objectives of this prospective pilot study is to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D Perfusion Ultrasound | Experimental | undergo 3D ultrasound perfusion imaging with perflutren |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| perflutren lipid microspheres | Drug |
|
| |
| 3D ultrasound |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel T. Chang | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3D Perfusion Ultrasound | Patients undergo 3D ultrasound perfusion imaging with perflutren lipid microspheres |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3D Perfusion Ultrasound | Patients undergo 3D ultrasound perfusion imaging with perflutren lipid microspheres |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | No cases were analyzed; analysis was not possible due to poor image quality. | Posted | Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment. |
|
|
Up to 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3D Perfusion Ultrasound | Patients undergo 3D ultrasound perfusion imaging with perflutren lipid microspheres |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lucas Kas Vitzthum | Stanford University | (650) 498-6000 | ccto-website@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2019 | Jun 16, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 11, 2021 | Jun 9, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C042852 | perflutren |
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| Diagnostic Test |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
| 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. | No cases were analyzed; analysis was not possible due to poor image quality. | Posted | 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. | No cases were analyzed; analysis was not possible due to poor image quality. | Posted | Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment. |
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
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| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |