Recurrent Renal Cell Carcinoma, Renal Cell Carcinoma
Conditions
Brief summary
This phase II trial studies how well contrast-enhanced ultrasound (CEUS) works for diagnosing patients with renal cell cancer (RCC) that has come back (recurrent) after an ablation. Diagnostic imaging, such as CEUS, may help find and monitor long term renal cell cancer recurrence following cryo or microwave ablation.
Detailed description
PRIMARY OBJECTIVE: 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.
Interventions
Given IV
PROCEDUREContrast-Enhanced Ultrasound
Undergo CEUS
PROCEDUREComputed Tomography
Undergo CT
PROCEDUREMagnetic Resonance Imaging
Undergo MRI
OTHERElectronic Health Record Review
Review electronic medical record
Sponsors
john eisenbrey
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously received cryotherapy or microwave therapy of RCC * 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 who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable * Patients with known sensitivities to the components of Lumason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal cell carcinoma recurrence | Up to 2 years | Baseline imaging will be reviewed and compared to the contrast enhanced imaging to diagnose recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of diagnostic imaging using 2D contrast-enhanced ultrasound (CEUS) with magnetic resonance/ computed tomography fusion | Up to 2 years | Contrast-enhanced imaging on all patients will be evaluated by radiologists at each site to determine if it increases the ability to diagnose recurrence compared to standard imaging. |
| Measurement with multimodality 3D CEUS to improve detection of recurrence | Up to 2 years | 3D CEUS imaging will be evaluated by radiologists at each site to determine if it improved detection of recurrence. |
Countries
United States
Contacts
CONTACTJohn Eisenbrey, PhD
Outcome results
None listed