Using ultrasound to detect early response to cancer immunotherapy
Serial Ultrasound of Solid Tumor Lesions to Detect Early Response to Cancer Immunotherapy
This study is testing if different ultrasound methods can help doctors see how well immunotherapy is working for patients with solid tumors after three weeks of treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05206942 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether changes in tumor perfusion parameters, measured by various ultrasound techniques after three weeks of immunotherapy, can predict the initial response to treatment in patients with solid tumors. It will compare the effectiveness of contrast-enhanced ultrasound (CEUS), conventional power Doppler, and Long Ensemble Angular-coherence Doppler (LEAD) ultrasound in assessing these changes. Additionally, the study will explore the correlation between tumor perfusion parameters and overall tumor burden, as well as progression-free survival over 12 months.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a pathology-confirmed diagnosis of cancer and at least one solid tumor lesion greater than 1 cm, who are scheduled to receive immunotherapy.
Not a fit: Patients with known hypersensitivity to the ultrasound contrast agent or those with comorbid conditions that impair their ability to participate may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to predict how well patients are responding to immunotherapy, potentially leading to more personalized treatment plans.
How similar studies have performed: Other studies have shown promise in using imaging techniques to assess treatment response, but this specific approach using ultrasound for early detection of response to immunotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * pathology-confirmed diagnosis of cancer * 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. Exclusion Criteria: * 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.
Where this trial is running
Palo Alto, California
- Stanford — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Alice C. Fan, MD — Stanford University
- Study coordinator: Christian R Hoerner
- Email: hoerner@stanford.edu
- Phone: 650-721-3206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.