Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 1

Conditions: Renal Cancer; Kidney Cancer

Treatments: Drug: Ultrasound with intravenous microbubble contrast injection

Study type: Interventional

Funder types: Other

Identifiers

NCT00671411

07-165

Details and patient eligibility

About

The purpose of this study is to evaluate the blood flow in kidney masses by using ultrasound microbubble contrast material, and to see if results from ultrasound contrast studies can predict if a kidney mass is benign or malignant. Patterns of blood flow in the kidney mass will be examined to see if:

1. benign kidney masses can be distinguished from kidney cancers and
2. if slow growing, lower risk cancers have different blood flow compared to clear cell cancer which is the most common type of kidney cancer.

Enrollment: 42 patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any adult patient who is planned or scheduled for surgical excision or biopsy of a solid or complex cystic renal mass would be eligible for the study
• Histology of the renal mass must be unknown at the time of enrollment
• Patients who have renal masses that are evident on conventional US imaging
• Patients will have a correlative abdominal CT and/or MRI

Exclusion criteria

• Patients with any history of cardiac shunts.
• Patients with history of pulmonary hypertension or unstable cardiopulmonary conditions, including patients on mechanical ventilation.
• Patients without peripheral IV access
• Pregnant patients and children
• Patients with any known contrast allergies, allergy to perflutren, or any components of Definity or microbubble contrast
• Patients who have renal masses that are not evident on conventional US imaging

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

1

Experimental group

Description:

Patients entering into this protocol will also have a preoperative renal contrast enhanced US for this research study. Renal mass US contrast enhancement results will be compared with surgical pathological findings to determine if contrast enhancement patterns of the renal masses correlate with benign and malignant histopathology, and/or malignant histologic subtype.

Treatment:

Drug: Ultrasound with intravenous microbubble contrast injection