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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA195443 | U.S. NIH Grant/Contract | View source | |
| NCI-2024-03676 | Other Identifier | CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-dimensional multi-parametric ultrasound imaging (3D-MPUS) | Participants will receive sulfur hexafluoride IV and undergo 3D-MPUS imaging over 20 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D-MPUS | Diagnostic Test | Participants will receive approximately < 20 minutes ultrasound scan to locate the lesion followed by acquisition of 3D-MPUS acquisition. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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).
| Baseline visit |
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Inclusion Criteria:
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.
Participant has given written informed consent to participate in this study.
Exclusion Criteria:
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)
Renal insufficiency with a creatinine level >1.5mg/dl, per our institutional guidelines (contradiction for CT imaging).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Marcellus, BS | Contact | (650) 723-4547 | dmarcel2@stanford.edu | |
| Suzanna Lee | Contact | +1 (858)-534-1475 | suzanna@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed El Kaffas, PhD | University of California, San Diego | Principal Investigator |
| Aya Kamaya, MD | Stanford University | Study Director |
| Andrej Lyshchik, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Recruiting | Palo Alto | California | 94305 | United States |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D004194 | Disease |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Thomas Jefferson University |
| Study Director |
| Aman Khurana, MD | University of California, San Diego | Study Director |
| Yuko Kono, MD, PhD, FAIUM, FAASLD | University of California, San Diego | Study Director |
| University of California, San Diego | Recruiting | San Diego | California | 92037 | United States |
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| Thomas Jefferson Hospital | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |