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

Last updated: August 16, 2024
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

3D-MPUS

Clinical Study ID

NCT05705219
IRB-68310
NCI-2024-03676
R01CA195443
  • Ages > 18
  • All Genders

Study 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

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 withultrasound

  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 localizedtreatments, after any prior treatment. For systemic combination treatments,prior treatment with either drug is allowed at the discretion of theinvestigators, including rechallenges with the same drug combination, forexample upon progression on imaging after a treatment break. For combinationtreatments where patients start treatment with different drugs at differenttimes, the start date of treatment is determined at the discretion of theinvestigators and can be the start date of the first drug or of the combinationtreatment. Repeat participation in the study is allowed, if patients areeligible again per their treatment plan

Exclusion

Exclusion Criteria:

  1. Participant has documented anaphylactic or other severe reaction to any ultrasoundcontrast media or polyethylene glycol (PEG).

  2. Participant has any comorbid condition** that, in the opinion of the treatingprovider or the Protocol Director, compromises the participant's ability toparticipate in the study.

  • Examples: any mental condition that compromises the ability to follow a consentdiscussion, or to make informed decisions (except if represented by a LegallyAuthorized Representative [LAR]); any condition that makes the participant nota good candidate to have ultrasound exams with contrast agent.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: 3D-MPUS
Phase:
Study Start date:
December 04, 2023
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Stanford University, School of Medicine

    Palo Alto, California 94305
    United States

    Active - Recruiting

  • Thomas Jefferson Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

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