Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast

Evaluation of Renal Masses Using Ultrasound Intravenous Microbubble Contrast

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.

Study Overview

• Status: Completed
• Conditions: Kidney Cancer; Renal Cancer
• Intervention / Treatment: Drug: Ultrasound with intravenous microbubble contrast injection

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1; 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.

Drug: Ultrasound with intravenous microbubble contrast injection; Intravenous line will be inserted. After the ultrasound microbubble contrast has been suspended into solution, contrast will be injected intrav via hand bolus with a total activated suspension of 0.2 mL (30 uL octaflouropropane),followed by 10 mL saline flush, with option to rebolus 4 addit time's for tot dose of 150 uL. Post contrast cine images of renal mass will be obtained on commercially available US units primarily using low mechanical index settings & Contrast Pulsed Sequence (CPS®) technique. Images will be acquired at predetermined intervals, for up to 8 min post contrast admin. Manufacturer's guidelines incl immediate post flush image capture, as well as post admin image capture at intervals as 1 min, 2 , 4 & 8 mins. Additional, temporary higher mechanical index imaging of kidney for the purpose of "flash" bubble destruction may be optionally triggered using manufacturer's preset settings & energy w/i FDA guidelines. This will only be performed while imaging the kidney.; Other Names: Conventional and contrast enhanced US images will be saved to the hard drive; and /or digitally archived, without any unique identifiers, and reviewed at a; later date. Images will be reviewed by three radiologists who are blinded to; the clinical, pathologic, and non ultrasound imaging findings. Grayscale; characteristics, qualitative and quantitative enhancement characteristics will; be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology	conclusion of study

Secondary Outcome Measures

Outcome Measure	Time Frame
To determine if clear cell renal malignancies can be predicted, or differentiated, from other less aggressive malignant subtypes, based on analysis of the data.	conclusion of study
To determine if contrast enhanced ultrasound of renal masses provides added value in predicting benign vs. malignant histology, when compared to the current routine evaluation of CT or MRI, and standard grey scale and Doppler US	conclusion of the study

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Scott Gerst, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 1, 2008
• First Submitted That Met QC Criteria: May 2, 2008
• First Posted (Estimate): May 5, 2008

Study Record Updates

• Last Update Posted (Estimate): December 28, 2015
• Last Update Submitted That Met QC Criteria: December 23, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Ultrasound; 07-165
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Kidney Neoplasms
• Other Study ID Numbers: 07-165