NCT05705219 Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients
| NCT ID | NCT05705219 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Liver Cancer, Adult |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-12-04 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2023-12-04 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial studies how well 3-dimensional multi-parametric ultrasound (3D MPUS) imaging works as a decision-support tool for patients with liver tumors undergoing therapy. Continuous and dynamic imaging of patients undergoing therapy is required to monitor early-phase treatment response.
Eligibility 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.
Contact & Investigator
Ahmed El Kaffas, PhD
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT05705219 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cancer, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05705219 currently recruiting?
Yes, NCT05705219 is actively recruiting participants. Contact the research team at dmarcel2@stanford.edu for enrollment information.
Where is the NCT05705219 trial being conducted?
This trial is being conducted at Palo Alto, United States, San Diego, United States, Philadelphia, United States.
Who is sponsoring the NCT05705219 clinical trial?
NCT05705219 is sponsored by University of California, San Diego. The principal investigator is Ahmed El Kaffas, PhD at University of California, San Diego. The trial plans to enroll 80 participants.
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