Liver CancerNCT02424955
Feasibility 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation
A study testing perflutren lipid microspheres and 3D ultrasound in people with Liver Cancer and Liver Tumor, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Liver Tumor, Hepatocellular Carcinoma
- What is being tested?
- perflutren lipid microspheres and 3D ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2014to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, School of Medicine
Stanford, California, 94305
About this study
Official title: Feasibility of 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation
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.
Read the detailed description
Primary Objective:
The primary objectives of this prospective pilot study is to:
- determine the feasibility and reproducibility of 3D contrast enhanced ultrasound imaging in liver cancer patients undergoing Stereotactic Ablative Radiotherapy and
- 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.
- Conditions
- Liver Cancer, Liver Tumor, Hepatocellular Carcinoma, Liver Carcinoma
- Being tested
- perflutren lipid microspheres, 3D ultrasound
- Keywords
- Liver cancer, Hepatocellular Carcinoma, Liver imaging, Stereotactic Ablative Radiotherapy, SABR
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perflutren lipid microspheresDrug
Also called Definity
3D ultrasoundDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| 3D Perfusion Ultrasound | Experimental | undergo 3D ultrasound perfusion imaging with perflutren Receives: Drug: perflutren lipid microspheres; Diagnostic Test: 3D ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study start18 Nov 2014
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel T. Chang, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424955
- Sponsor's protocol ID
- IRB-30071
- Other IDs
- IRB-30071, HEP0048
- Status last verified
- Jun 2023
- First submitted
- 16 Apr 2015
- Last updated
- 11 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation
- ClinicalTrials.gov ID
- NCT02424955
- Acronym / sponsor ID
- IRB-30071
- Conditions
- Liver Cancer, Liver Tumor, Hepatocellular Carcinoma, Liver Carcinoma
- Keywords
- Liver cancer, Hepatocellular Carcinoma, Liver imaging, Stereotactic Ablative Radiotherapy, SABR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 18 Nov 2014 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Posted 11 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- determine the feasibility and reproducibility of 3D contrast enhanced ultrasound imaging in liver cancer patients undergoing Stereotactic Ablative Radiotherapy and
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D Perfusion Ultrasound | Experimental | Drug: perflutren lipid microspheres, Diagnostic Test: 3D ultrasoundundergo 3D ultrasound perfusion imaging with perflutren |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perflutren lipid microspheresAlso: Definity | Drug | 3D Perfusion Ultrasound |
| 3D ultrasound | Diagnostic test | 3D Perfusion Ultrasound |
Primary outcome
Changes in Blood Perfusion (Blood Volume)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel T. Chang principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perflutren lipid microspheres and 3D ultrasound in people with Liver Cancer and Liver Tumor, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Blood Perfusion (Blood Volume) (time frame: Baseline (pre-treatment), 0-7 days post treatment, 2-4 months post treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.