Solid TumorNCT05206942
Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy
A study testing Doppler ultrasound, Long Ensemble Angular-coherence Doppler [LEAD] ultrasound and Contrast-enhanced ultrasound (CEUS) in people with Solid Tumor, run by Stanford University at 1 site in United States.
Trial summary
Primary objective is to assess whether changes in quantitative tumor perfusion parameters after 3 weeks of treatment, as measured by CEUS, can predict initial objective response to therapy, defined by current standard-of-care Secondary objectives are to evaluate if there is an optimal ultrasound imaging modality (CEUS… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Doppler ultrasound, Long Ensemble Angular-coherence Doppler [LEAD] ultrasound and Contrast-enhanced ultrasound (CEUS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2022to 28 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 years of age or older
- at least one solid tumor lesion greater than 1 cm in diameter (primary tumor and/or at metastatic site), amenable to ultrasound imaging
- planned to be treated with ICI therapy (single agent or in combination with any other drug)
- written informed consent.
- prior use of any ICI is not necessarily excluded, and patients may be included with the approval of the Protocol Director
- Subjects may participate in the study more than once at the discretion of the Protocol Director, for example, if they receive different lines of treatment that all qualify for the study.
Who cannot join
- known hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG)
- any comorbid condition that, in the opinion of the treating provider or the Protocol Directors, compromises the participant's ability to participate in the study
- Examples: any mental condition that compromises the ability to follow a consent discussion, or to make informed decisions (except if represented by a Legally Authorized Representative [LAR]), or to have ultrasound exams.
Trial locations and contacts
1 site in 1 country.
About this study
Primary objective is to assess whether changes in quantitative tumor perfusion parameters after 3 weeks of treatment, as measured by CEUS, can predict initial objective response to therapy, defined by current standard-of-care
Secondary objectives are to evaluate if there is an optimal ultrasound imaging modality (CEUS or conventional power Doppler or LEAD ultrasound) or optimal time point to predict initial objective response and to assess the correlation of tumor perfusion parameters with change in overall tumor burden, change in diameter on a per-lesion basis, and with 12-month progression-free survival (PFS).
- Conditions
- Solid Tumor
- Being tested
- Doppler ultrasound, Long Ensemble Angular-coherence Doppler [LEAD] ultrasound, Contrast-enhanced ultrasound (CEUS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler ultrasoundDiagnostic test
Power Doppler measurements will be made using a portable Siemens S2000 or S3000 ultrasound scanner
Long Ensemble Angular-coherence Doppler [LEAD] ultrasoundDiagnostic test
Long Ensemble Angular-coherence Doppler measurements will be made using a Verasonics Vantage 256 scanner
Contrast-enhanced ultrasound (CEUS)Diagnostic test
Contrast-enhanced ultrasound measurements will be made using Lumason IV contrast injection followed by an injection of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Experimental | Patients receiving standard of care immune checkpoint inhibitor are followed with the ultrasound studies at treatment baseline, 3 weeks and 6 weeks. Receives: Diagnostic Test: Doppler ultrasound; Diagnostic Test: Long Ensemble Angular-coherence Doppler [LEAD] ultrasound; Diagnostic Test: Contrast-enhanced ultrasound (CEUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial objective response per RECIST v1.1
Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1
Measured: 16 weeks
Secondary outcomes (3)
Initial relative change in tumor burden
defined as relative change in the sum of diameters of all measurable tumors, assessed between treatment 'baseline' and first on-treatment response evaluation
Measured: 16 weeks
Initial lesion response
defined as the relative change in tumor diameter of a single lesion between treatment 'baseline' and first on-treatment response evaluation
Measured: 16 weeks
progression-free survival (PFS)
defined as not having experienced any PD per RECIST v1.1
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start21 Mar 2022
- Primary completion28 Sep 2026 (estimated)
- Study completion28 Sep 2026 (estimated)
Why it stopped: NIH funding expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alice C. Fan, MD, Principal investigator, Stanford UniversityJeremy Dahl, Ph.D, Principal investigator, Stanford UniversityAya Kamaya, M.D, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206942
- Sponsor's protocol ID
- IRB-59526
- Other IDs
- NCI-2022-02835, 5R21CA259756-02
- Status last verified
- May 2026
- First submitted
- 12 Jan 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy
- ClinicalTrials.gov ID
- NCT05206942
- Acronym / sponsor ID
- IRB-59526
- Conditions
- Solid Tumor
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: NIH funding expired
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 28 Sep 2026 (estimated)
- Study completion
- 28 Sep 2026 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective is to assess whether changes in quantitative tumor perfusion parameters after 3 weeks of treatment, as measured by CEUS, can predict initial objective response to therapy, defined by current standard-of-care
Secondary objectives are to evaluate if there is an optimal ultrasound imaging modality (CEUS or conventional power Doppler or LEAD ultrasound) or optimal time point to predict initial objective response and to assess the correlation of tumor perfusion parameters with change in overall tumor burden, change in diameter on a per-lesion basis, and with 12-month progression-free survival (PFS).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | Experimental | Diagnostic Test: Doppler ultrasound, Diagnostic Test: Long Ensemble Angular-coherence Doppler [LEAD] ultrasound, Diagnostic Test: Contrast-enhanced ultrasound (CEUS)Patients receiving standard of care immune checkpoint inhibitor are followed with the ultrasound studies at treatment baseline, 3 weeks and 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- at least one solid tumor lesion greater than 1 cm in diameter (primary tumor and/or at metastatic site), amenable to ultrasound imaging
- planned to be treated with ICI therapy (single agent or in combination with any other drug)
- written informed consent.
- Subjects may participate in the study more than once at the discretion of the Protocol Director, for example, if they receive different lines of treatment that all qualify for the study.
Key exclusion criteria (3 listed)
- known hypersensitivity to sulfur hexafluoride lipid microsphere or its components, such as polyethylene glycol (PEG)
- any comorbid condition that, in the opinion of the treating provider or the Protocol Directors, compromises the participant's ability to participate in the study
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 |
|---|---|---|
| Doppler ultrasoundPower Doppler measurements will be made using a portable Siemens S2000 or S3000 ultrasound scanner | Diagnostic test | Ultrasound |
| Long Ensemble Angular-coherence Doppler [LEAD] ultrasoundLong Ensemble Angular-coherence Doppler measurements will be made using a Verasonics Vantage 256 scanner | Diagnostic test | Ultrasound |
| Contrast-enhanced ultrasound (CEUS)Contrast-enhanced ultrasound measurements will be made using Lumason IV contrast injection followed by an injection of normal saline | Diagnostic test | Ultrasound |
Primary outcome
Initial objective response per RECIST v1.1
Time frame: 16 weeks
Initial objective response is defined as having either Complete Response (CR) or Partial Response (PR) per RECIST v1.1
3 secondary outcomes
Initial relative change in tumor burden
Time frame: 16 weeks
Initial lesion response
Time frame: 16 weeks
progression-free survival (PFS)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Alice C. Fan, MD principal investigator
Stanford University
Jeremy Dahl, Ph.D principal investigator
Stanford University
Aya Kamaya, M.D 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 Doppler ultrasound, Long Ensemble Angular-coherence Doppler [LEAD] ultrasound and Contrast-enhanced ultrasound (CEUS) in people with Solid 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 6 inclusion and 3 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: paused, as of the sponsor's last update on 6 May 2026. 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?
Results are not available in the source record.
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?
Initial objective response per RECIST v1.1 (time frame: 16 weeks). 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 6 May 2026.