Clinical trial · Interventional
Contrast-Enhanced Ultrasound in Predicting Treatment Response in Patients With Kidney Cancer Undergoing Cryosurgery
Contrast-Enhanced Ultrasound for the Evaluation of Renal Cell Carcinoma Cryoablation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated by the IRB
Summary
Brief summary (as posted)
This pilot clinical trial compares the imaging results of contrast-enhanced ultrasound to contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT), the current clinical standard, in predicting treatment response in patients with kidney cancer undergoing cryosurgery (a procedure in which an extremely cold liquid or an instrument called a cryoprobe is used to freeze and destroy abnormal tissue). Using contrast-enhanced ultrasound that does not involve a dye may help patients avoid side effects from a dye that is usually used in MRI or CT and may help doctors measure blood flow and determine whether the cryosurgery procedure treated the kidney tumor.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dynamic Contrast-Enhanced Ultrasound Imaging | Procedure | — | UNRESOLVED |
| Perflutren Protein-Type A Microspheres | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (contrast-enhanced ultrasound)
- description
- Patients receive perflutren protein-type A microspheres IV and then undergo contrast-enhanced ultrasound imaging the morning prior to cryosurgery and at 3-4 months post treatment during Magnetic Resonance Imaging (MRI) or computed tomography (CT) follow up.
- interventionNames
- Drug: Perflutren Protein-Type A Microspheres
- Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging
Primary outcomes (5)
- measure
- Sensitivity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma
- timeFrame
- Up to 3-4 months after cryosurgery
- description
- Sensitivity will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Be scheduled for a percutaneous cryoablation of a renal mass * Be medically stable * If a female of child-bearing potential, 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 (New York Heart Association \[NYHA\] 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 who have received any contrast medium (X-ray, MRI, CT, or ultrasound \[US\]) in the 24 hours prior to the research US exam * 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 * Patients with renal insufficiency such that they can not get intravenous contrast as part of screening or follow-up
References
Publications (0)
Data not yet available