Clinical trial NCT05705219: Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients
Official title: Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients With Abdominal and Pelvic Tumors Undergoing Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cancer, Adult
Keywords: Diagnostic Study
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-01-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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. 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.


Eligibility criteria: Inclusion Criteria:

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 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.

   * 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.

Primary outcomes:
measure: Diagnostic yield of the 3D-MPUS data acquisition
timeFrame: Baseline visit (average approximately to 45 minutes to perform scan)
Secondary outcomes:
measure: Inter-reader agreement for 3D-MPUS measurements at first scan
timeFrame: Baseline visit (average approximately to 45 minutes to assess scan)
measure: Relationship between baseline and one-month 3D-MPUS measurements and treatment response after three-months
timeFrame: Baseline and 3 months post treatment
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
city: Philadelphia
country: United States
facility: Thomas Jefferson Hospital
state: Pennsylvania
Study officials:
affiliation: Stanford University
name: Aya Kamaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University
name: Andrej Lyshchik, MD, PhD
role: STUDY_DIRECTOR
References: