30 Participants Needed

Ultrasound Techniques for Detecting Immunotherapy Response in Solid Tumors

CR
Overseen ByChristian R Hoerner
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
Must be taking: ICI therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Contrast-enhanced ultrasound (CEUS) for detecting immunotherapy response in solid tumors?

Research shows that contrast-enhanced ultrasound (CEUS) can help predict and evaluate treatment responses in various cancers, such as liver and breast cancer, by providing detailed images of blood flow and tissue changes. This suggests that CEUS might also be effective in assessing how well immunotherapy is working in solid tumors.12345

Is ultrasound safe for detecting immunotherapy response in solid tumors?

The research articles provided do not contain specific safety data about ultrasound techniques like Contrast-enhanced ultrasound (CEUS) or Doppler ultrasound for detecting immunotherapy response in solid tumors. Therefore, no relevant safety information is available from these sources.678910

How is the ultrasound technique for detecting immunotherapy response in solid tumors different from other treatments?

This treatment is unique because it uses contrast-enhanced ultrasound (CEUS) to predict and evaluate the response to immunotherapy in solid tumors, which is a non-invasive imaging technique that provides real-time information about how well the treatment is working, unlike traditional methods that may require more invasive procedures.123411

What is the purpose of this trial?

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-careSecondary 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).

Research Team

Aya Kamaya, MD | Stanford Medicine

Aya Kamaya, MD

Principal Investigator

Stanford University

AC

Alice C. Fan, MD

Principal Investigator

Stanford University

JD

Jeremy Dahl, Ph.D

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for adults with a confirmed cancer diagnosis who are about to start treatment with immunotherapy drugs like ipilimumab plus nivolumab. They must have at least one solid tumor lesion larger than 1 cm that can be seen on an ultrasound. People allergic to sulfur hexafluoride lipid microsphere or PEG, or those with other serious health issues, cannot participate.

Inclusion Criteria

My cancer diagnosis has been confirmed by lab tests.
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.
I am scheduled for immune checkpoint inhibitor therapy.
See 3 more

Exclusion Criteria

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
I am allergic to sulfur hexafluoride lipid microsphere or PEG.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care immune checkpoint inhibitor and are followed with ultrasound studies at treatment baseline, 3 weeks, and 6 weeks

6 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of tumor burden and progression-free survival

12 months

Treatment Details

Interventions

  • Contrast-enhanced ultrasound (CEUS)
  • Doppler ultrasound
  • Long Ensemble Angular-coherence Doppler [LEAD] ultrasound
Trial Overview The study aims to see if early changes in blood flow within tumors, as shown by different types of ultrasound (Doppler, LEAD, and contrast-enhanced), can predict how well the treatment works after three weeks. It also looks at which ultrasound method and timing might best forecast treatment response and survival without disease progression over 12 months.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: UltrasoundExperimental Treatment3 Interventions
Patients receiving standard of care immune checkpoint inhibitor are followed with the ultrasound studies at treatment baseline, 3 weeks and 6 weeks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 21 lymphoma patients, B-mode ultrasound (B-US) effectively predicted treatment response, showing a median lymphoma shrinkage of 34% in patients achieving complete remission (CR) by day 30.
Contrast-enhanced ultrasound (CEUS) did not provide additional predictive value for treatment response, as enhancement patterns were similar in both complete and progressive disease patients, indicating that B-US may be the more reliable method for early response assessment.
Assessment of Early Therapy Response of Non-Hodgkin's and Hodgkin's Lymphoma Using B-Mode Ultrasound and Dynamic Contrast-Enhanced Ultrasound.Trenker, C., Kümpel, J., Michel, C., et al.[2022]
In a study of 24 patients with unresectable hepatocellular carcinoma (HCC) treated with tyrosine kinase inhibitors and anti-PD-1 therapy, contrast-enhanced ultrasound (CEUS) was found to be as effective as contrast-enhanced MRI/CT in evaluating treatment response, showing a high degree of agreement in assessing tumor necrosis.
CEUS demonstrated superior performance compared to unenhanced ultrasound in determining treatment outcomes, although there was poor agreement between traditional RECIST criteria and the modified RECIST used with CEUS.
Response Evaluation Using Contrast-Enhanced Ultrasound for Unresectable Advanced Hepatocellular Carcinoma Treated With Tyrosine Kinase Inhibitors Plus Anti-PD-1 Antibody Therapy.Zhao, CK., Guan, X., Pu, YY., et al.[2023]
In a study of 66 patients with unresectable hepatocellular carcinoma (HCC) undergoing combined immune checkpoint inhibitor and anti-angiogenesis therapies, certain contrast-enhanced ultrasound (CEUS) parameters were found to significantly differ between responders and non-responders, indicating their potential as predictive tools for treatment efficacy.
The rising time (RT) ratio was identified as the only independent factor associated with treatment response, with a median RT ratio of 36.9 for responders compared to 58.9 for non-responders, suggesting that lower RT ratios correlate with better progression-free survival.
Quantitative Parameters of Contrast-Enhanced Ultrasound Predicting the Response to Combined Immune Checkpoint Inhibitor and Anti-angiogenesis Therapies for Unresectable Hepatocellular Carcinoma.Zhang, Y., Zheng, R., Liu, M., et al.[2023]

References

Assessment of Early Therapy Response of Non-Hodgkin's and Hodgkin's Lymphoma Using B-Mode Ultrasound and Dynamic Contrast-Enhanced Ultrasound. [2022]
Response Evaluation Using Contrast-Enhanced Ultrasound for Unresectable Advanced Hepatocellular Carcinoma Treated With Tyrosine Kinase Inhibitors Plus Anti-PD-1 Antibody Therapy. [2023]
Quantitative Parameters of Contrast-Enhanced Ultrasound Predicting the Response to Combined Immune Checkpoint Inhibitor and Anti-angiogenesis Therapies for Unresectable Hepatocellular Carcinoma. [2023]
Contrast enhanced ultrasound quantitative parameters for assessing neoadjuvant chemotherapy response in patients with locally advanced breast cancer. [2022]
Contrast-enhanced ultrasound of breast tumors: an initial experience. [2022]
Increased frequency of acute reactions to iodinated contrast media in cancer patients treated with anti-CTLA-4 immunomodulatory antibodies. [2018]
Sonographic Findings in Inflammatory Arthritis Secondary to Immune Checkpoint Inhibition: A Case Series. [2022]
Detection of immune-related adverse events by medical imaging in patients treated with anti-programmed cell death 1. [2019]
RS3PE Following Treatment With Combination of Hormonal Therapies Plus Ipilimumab in a Patient With Metastatic Prostate Cancer. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Echocardiography Core Laboratory Reproducibility of Cardiac Safety Assessments in Cardio-Oncology. [2020]
Assessment of response of neoadjuvant chemotherapy in carcinoma breast patients by high-frequency ultrasound. [2022]
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