RECRUITING

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

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Conditions

Liver Cancer, AdultDiagnostic Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-04
Study Completion:2028-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05705219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Participant is age \>/=18 years.
  3. 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. 4. Participant is willing to comply with protocol requirements.
  5. 5. Participant has given written informed consent to participate in this study.
  6. * 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.
  1. 1. Participant has documented anaphylactic or other severe reaction to any ultrasound contrast media or polyethylene glycol (PEG).
  2. 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. 3. Participant is pregnant (positive urine or serum beta-hCG) or lactating.
  4. 4. Presence of cardiac shunt or presence of pulmonary hypertension (contradiction for ultrasound contrast agent)
  5. 5. Renal insufficiency with a creatinine level \>1.5mg/dl, per our institutional guidelines (contradiction for CT imaging).
  6. * 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.

Contacts and Locations

Study Contact

David Marcellus, BS
CONTACT
(650) 723-4547
dmarcel2@stanford.edu
Suzanna Lee
CONTACT
+1 (858)-534-1475
suzanna@health.ucsd.edu

Principal Investigator

Ahmed El Kaffas, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Diego
Aya Kamaya, MD
STUDY_DIRECTOR
Stanford University
Andrej Lyshchik, MD, PhD
STUDY_DIRECTOR
Thomas Jefferson University
Aman Khurana, MD
STUDY_DIRECTOR
University of California, San Diego
Yuko Kono, MD, PhD, FAIUM, FAASLD
STUDY_DIRECTOR
University of California, San Diego

Study Locations (Sites)

Stanford University, School of Medicine
Palo Alto, California, 94305
United States
University of California, San Diego
San Diego, California, 92037
United States
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Ahmed El Kaffas, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Diego
  • Aya Kamaya, MD, STUDY_DIRECTOR, Stanford University
  • Andrej Lyshchik, MD, PhD, STUDY_DIRECTOR, Thomas Jefferson University
  • Aman Khurana, MD, STUDY_DIRECTOR, University of California, San Diego
  • Yuko Kono, MD, PhD, FAIUM, FAASLD, STUDY_DIRECTOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-04
Study Completion Date2028-12-31

Study Record Updates

Study Start Date2023-12-04
Study Completion Date2028-12-31

Terms related to this study

Keywords Provided by Researchers

  • Diagnostic Study

Additional Relevant MeSH Terms

  • Liver Cancer, Adult