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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Diego

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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*.

Participant is age >/=18 years.

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

Participant is willing to comply with protocol requirements.

Disqualifiers

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

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.

Participant is pregnant (positive urine or serum beta-hCG) or lactating.

Presence of cardiac shunt or presence of pulmonary hypertension (contradiction for ultrasound contrast agent)

Trial population

1. The participant is about to undergo a new course of therapy for primary or metastatic cancer in the abdominal or pelvic region. 2. The participant is age \> 18 years. 3. Participant has at least one target lesion (≥1cm and \<14cm) 4. The participant is willing to comply with protocol requirements. 5. The participant has the ability to understand and the willingness to sign a written informed consent document.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 3D-MPUS

    Diagnostic test

    Participants will receive approximately \< 20 minutes ultrasound scan to locate the lesion followed by acquisition of 3D-MPUS acquisition.

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: 3-dimensional multi-parametric ultrasound imaging (3D-MPUS)1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic yield of the 3D-MPUS data acquisition

Diagnostic yield will be the percentage of non-missing measurements (per reader, per measurement) Participants with successful measurements of the following parameters (following administration of a contrast agent). * peak enhancement (PE)

Time frame
Baseline visit

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of California, San Diego

Lead sponsor

National Cancer Institute (NCI)

Collaborator