Using 3D Ultrasound to Help Treat Liver Cancer
Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients With Abdominal and Pelvic Tumors Undergoing Therapy
University of California, San Diego · NCT05705219
This study tests if a special 3D ultrasound can help doctors better track how well treatment is working for patients with liver tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Diego (other) |
| Locations | 3 sites (Palo Alto, California and 2 other locations) |
| Trial ID | NCT05705219 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of 3-dimensional multi-parametric ultrasound (3D MPUS) as a decision-support tool for patients with liver tumors undergoing therapy. The study focuses on continuous and dynamic imaging to monitor early-phase treatment responses, providing additional quantitative functional and tissue characterization information alongside traditional anatomical assessments. Participants will be those who are about to start a new course of cancer therapy and have suitable target lesions for ultrasound imaging.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are about to begin a new course of cancer therapy and have at least one target liver lesion suitable for ultrasound imaging.
Not a fit: Patients who do not have liver tumors or are not planning to undergo any cancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance treatment decision-making and improve outcomes for patients with liver cancer.
How similar studies have performed: While the use of ultrasound imaging in cancer treatment is established, the specific application of 3D MPUS as a decision-support tool is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant has untreated liver metastases from colorectal low-grade adenocarcinoma (biopsy-proven and/or characteristic findings on CT, MRI, or FDG-PET) and has planned to undergo a new course of cancer therapy\*. 2. Participant is age \>/=18 years. 3. Participant has at least one target lesion that measures ≥1cm in diameter (minimum size according to RECIST 1.1) with a maximum diameter of 14cm amenable to imaging with ultrasound 4. Participant is willing to comply with protocol requirements. 5. Participant has given written informed consent to participate in this study. * Any line of cancer therapy is allowed, including systemic and localized treatments, after any prior treatment. For systemic combination treatments, prior treatment with either drug is allowed at the discretion of the investigators, including rechallenges with the same drug combination, for example upon progression on imaging after a treatment break. For combination treatments where patients start treatment with different drugs at different times, the start date of treatment is determined at the discretion of the investigators and can be the start date of the first drug or of the combination treatment. Repeat participation in the study is allowed, if patients are eligible again per their treatment plan. Exclusion Criteria: 1. Participant has documented anaphylactic or other severe reaction to any ultrasound contrast media or polyethylene glycol (PEG). 2. Participant has any comorbid condition\*\* that, in the opinion of the treating provider or the Protocol Director, compromises the participant's ability to participate in the study. 3. Participant is pregnant (positive urine or serum beta-hCG) or lactating. 4. Presence of cardiac shunt or presence of pulmonary hypertension (contradiction for ultrasound contrast agent) 5. Renal insufficiency with a creatinine level \>1.5mg/dl, per our institutional guidelines (contradiction for CT imaging). * 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 \[LAR\]); any condition that makes the participant not a good candidate to have ultrasound exams with contrast agent.
Where this trial is running
Palo Alto, California and 2 other locations
- Stanford University, School of Medicine — Palo Alto, California, United States (RECRUITING)
- University of California, San Diego — San Diego, California, United States (RECRUITING)
- Thomas Jefferson Hospital — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Ahmed El Kaffas, PhD — University of California, San Diego
- Study coordinator: David Marcellus, BS
- Email: dmarcel2@stanford.edu
- Phone: (650) 723-4547
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.
Conditions: Liver Cancer, Adult, Diagnostic Study