Clinical trial · Interventional
Pilot 3D Contrast-Enhanced Ultrasound Imaging to Predict Treatment Response in Liver Metastases
Pilot Technical Feasibility Study on 3D Contrast-enhanced Ultrasound Imaging and to Assess Whether Change in Ultrasound 3D Perfusion Pattern Can Predict Treatment Response
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients are invited to participate in a research study of liver perfusion (how blood flows to the liver over time). Researchers hope to learn whether perfusion characteristics of liver metastases may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment. Patients were selected as a possible participant in this study because they are identified as having liver metastases
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Liver Metastases | Colon Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dynamic contrast-enhanced ultrasound imaging | Procedure | — | UNRESOLVED |
| Electromagnetic Tracking Device | Device | — | UNRESOLVED |
| Optical Tracking Device | Device | — | UNRESOLVED |
| Perflutren | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (3D contrast-enhanced ultrasound imaging)
- description
- Patients undergo 3D dynamic contrast-enhanced ultrasound imaging before initiation of chemotherapy and at 2 weeks.
- interventionNames
- Procedure: Dynamic contrast-enhanced ultrasound imaging
- Device: Optical Tracking Device
- Device: Electromagnetic Tracking Device
- Drug: Perflutren
Primary outcomes (3)
- measure
- Measurements of blood flow, in terms of comparison of the perfusion parameters of the lesion as a predictor of tumor response to treatment and use as a biomarker for response to treatment
- timeFrame
- Baseline
- description
- Descriptive statistics will be presented for lesion size, by lesion type, and across lesion types. Lesion shape, depth, vascularization, and border definition will also be categorized by dose and lesion type. Based on the unenhanced ultrasound, the target lesion to liver echogenicity will be categorized by lesion type. Based on the Definity®-enhanced ultrasound, the pattern of enhancement of the target lesion will be summarized by lesion type.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria
* Provides written Informed Consent and is willing to comply with protocol requirements.
* Has at least 1 focal lesion in liver or kidney
* Patient may be (i) in the process of receiving treatment (1 scan session), (ii) never treated (3 scan sessions) or (iii) changing treatment regimen/ type and/or receiving a new form of treatment and/or has been on a treatment break ('holiday')(3 scan session)
* Is at least18 years of age.
Exclusion Criteria
* Is determined by the Investigator that the subject is clinically unsuitable for the study.
* Known right to left cardiac shunt, bidirectional or transient.
* Hypersensitivity to perflutren.
* Hypersenstivity to the contrast agent Definity.
* Pregnant and lactating womenReferences
Publications (0)
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