Contrast-Enhanced Ultrasound Imaging for Diagnosing Recurrent Renal Cell Carcinoma (RCC) Post Ablation
NCT ID: NCT05641935
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
210 participants
INTERVENTIONAL
2022-11-03
2027-08-31
Brief Summary
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Detailed Description
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I. To characterize and compare the sensitivity, specificity, positive and negative predictive value, and inter-reader agreement of 2D contrast-enhanced ultrasound (CEUS) and contrast-enhanced computed tomography (CT)/magnetic resonance imaging (MRI) for detecting recurrent or residual renal cell carcinoma (RCC) following ablation, using a combination of standard of care imaging follow-up and tissue pathology as a reference standard.
SECONDARY OBJECTIVES:
I. To evaluate the potential improvement to the qualitative assessments of 2D CEUS when fused with the patient's pre-treatment cross sectional imaging.
II. To assess the potential added value of using multi-modality volumetric CEUS for detecting RCC recurrence post ablation.
III. To explore the use of quantitative imaging parameters extracted from 2D/3D CEUS datasets to determine if this improves the overall performance of CEUS.
EXPLORATORY OBJECTIVE:
I. An advanced Doppler technique designed for detection of slower flow will also be investigated as a non-contrast based approach for detecting recurrent disease.
OUTLINE:
Patients receive Lumason intravenously (IV) and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (CEUS with MRI/CT)
Patients receive Lumason IV and undergo CEUS imaging with MRI/CT on study. Patients' electronic medical record is reviewed every 6 months throughout study.
Sulfur Hexafluoride Lipid Microspheres
Given IV
Contrast-Enhanced Ultrasound
Undergo CEUS
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Electronic Health Record Review
Review electronic medical record
Interventions
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Sulfur Hexafluoride Lipid Microspheres
Given IV
Contrast-Enhanced Ultrasound
Undergo CEUS
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Electronic Health Record Review
Review electronic medical record
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has available contrast enhanced (CE)-MRI or CE-CT imaging prior to ablative therapy
* Have previously had or are scheduled to have a contrast-enhanced MRI/CT for the monitoring of RCC recurrence within 4 weeks of the CEUS study
* Be at least 18 years of age
* Be medically stable
* If a female of child-bearing age, must have a negative pregnancy test
* Have signed Informed Consent to participate in the study
Exclusion Criteria
* Patients with known sensitivities to the components of Lumason
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
john eisenbrey
OTHER
Responsible Party
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john eisenbrey
Associate Professor, Radiology
Locations
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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JT 24546
Identifier Type: OTHER
Identifier Source: secondary_id
22F.825
Identifier Type: -
Identifier Source: org_study_id
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