Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients

Trial ID or NCT#

NCT05705219

Status

recruiting iconRECRUITING

Purpose

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. 3D-MPUS is an inexpensive and safe method, which may provide complementary quantitative functional (perfusion) and tissue characterization information to anatomical radiological assessment or blood biomarkers.

Official Title

Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients With Abdominal and Pelvic Tumors Undergoing Therapy

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Participant is planned to undergo a new course of cancer therapy\*.2. Participant is age \>/=18 years.3. Participant has at least one target lesion (≥1cm and \<14cm) amenable to imaging with ultrasound4. Participant is willing to comply with protocol requirements.5. Participant has given written informed consent to participate in this study.
    1. * 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. 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.
    1. * 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.

Investigator(s)

Aya Kamaya, MD
Aya Kamaya, MD
Radiologist
Professor of Radiology (Body Imaging)

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Contact

David Marcellus, BS
650-723-4547