To hear about similar clinical trials, please enter your email below
Trial Title:
Development of 3D Multi-Parametric Ultrasound (MPUS) as a Decision Support Tool for Patients
NCT ID:
NCT05705219
Condition:
Liver Cancer, Adult
Conditions: Official terms:
Carcinoma, Hepatocellular
Conditions: Keywords:
Diagnostic Study
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
3D-MPUS
Description:
Participants will receive approximately < 20 minutes ultrasound scan to locate the lesion
followed by acquisition of 3D-MPUS acquisition.
Arm group label:
3-dimensional multi-parametric ultrasound imaging (3D-MPUS)
Other name:
3-dimensional multi-parametric ultrasound imaging
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Stanford University, School of Medicine
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Marcellus, BS
Phone:
650-723-4547
Email:
dmarcel2@stanford.edu
Investigator:
Last name:
Ahmed El Kaffas, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Aya Kamaya, MD
Email:
Principal Investigator
Facility:
Name:
Thomas Jefferson Hospital
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Andrej Lyshchik, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
John Eisenbrey, PhD
Email:
Sub-Investigator
Start date:
December 4, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Stanford University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Stanford University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05705219
