Clinical trial · Interventional
Two and Three Dimensional Contrast-enhanced Ultrasound for Screening of Renal Cell Carcinoma Recurrence Following Cryoablation
Two and Three Dimensional Contrast-Enhanced Ultrasound for Screening of Renal Cell Carcinoma Recurrence Following Cryoablation
- 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)
The purpose of the proposed trial is to determine whether contrast-enhanced ultrasound (CEUS) can be used to assess the recurrence of renal cell carcinoma (RCC) after cryoablation compared to contrast enhanced CT or MR (the standard evaluation). This study involves the off-label use of an FDA-approved ultrasound contrast agent, Optison that flows in the vascularity. CEUS will be performed by both two and three dimensional ultrasound to examine post-cryoablation vascularity changes to screen for recurrent disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optison | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Contrast Ultrasound Reccurence Screening
- description
- Patients scheduled for MRI/CT follow up of a renal cancer previously treated by cryoablation therapy who will also undergo a contrast-enhanced ultrasound exam. This is a one-time imaging study and contrast ultrasound exams will be compared to the clinically scheduled MRI/CT.
- interventionNames
- Drug: Optison
Primary outcomes (1)
- measure
- The Sensitivity of Detecting RCC Recurrence (Using Contrast-enhanced MRI as a Reference Standard) on a Single Contrast-enhanced Ultrasound Exam.
- timeFrame
- 8 months post cryoblation
- description
- Patients scheduled for follow up contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) of a previously cryoablatated renal cell carcinoma (RCC) through Thomas Jefferson University's Urology clinic will undergo a single ultrasound exam using contrast enhanced ultrasound. Ultrasound imaging will be performed using a state of the art ultrasound scanner with two and three dimensional curvilinear transducers.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously received cryotherapy of RCC. * Be scheduled for contrast-enhanced MRI/CT to monitoring of RCC recurrence as part of their 8, 12, 18, 24, or 36 month CT/MRI follow up. * 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: * Females who are pregnant or nursing. * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example: * Patients on life support or in a critical care unit. * Patients with unstable occlusive disease (eg, crescendo angina) * Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia. * Patients with uncontrolled congestive heart failure (NYHA Class IV) * Patients with recent cerebral hemorrhage. * Patients with known sensitivities to albumin, blood, or blood products * Patients who have undergone surgery within 24 hours prior to the study sonographic examination. * Patients with known hypersensitivity to perflutren * Patients with cardiac shunts. * Patients with congenital heart defects. * Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli. * Patients with respiratory distress syndrome.
References
Publications (1)
- RESULTEisenbrey JR, Shaw CM, Lyshchik A, Machado P, Lallas CD, Trabulsi EJ, Merton DA, Fox TB, Liu JB, Brown DB, Forsberg F. Contrast-Enhanced Subharmonic and Harmonic Ultrasound of Renal Masses Undergoing Percutaneous Cryoablation. Acad Radiol. 2015 Jul;22(7):820-6. doi: 10.1016/j.acra.2015.03.008. Epub 2015 Apr 14. PMID 25882093