Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast
Primary Purpose
Renal Cancer, Kidney Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ultrasound with intravenous microbubble contrast injection
Sponsored by
About this trial
This is an interventional diagnostic trial for Renal Cancer focused on measuring Ultrasound, 07-165
Eligibility Criteria
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
Sites / Locations
- Memorial Sloan-Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm 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.
Outcomes
Primary Outcome Measures
To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology
Secondary Outcome Measures
To determine if clear cell renal malignancies can be predicted, or differentiated, from other less aggressive malignant subtypes, based on analysis of the data.
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
Full Information
NCT ID
NCT00671411
First Posted
May 1, 2008
Last Updated
December 23, 2015
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00671411
Brief Title
Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast
Official Title
Evaluation of Renal Masses Using Ultrasound Intravenous Microbubble Contrast
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
Brief Summary
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:
benign kidney masses can be distinguished from kidney cancers and
if slow growing, lower risk cancers have different blood flow compared to clear cell cancer which is the most common type of kidney cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cancer, Kidney Cancer
Keywords
Ultrasound, 07-165
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Ultrasound with intravenous microbubble contrast injection
Other Intervention Name(s)
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.
Intervention Description
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.
Primary Outcome Measure Information:
Title
To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology
Time Frame
conclusion of study
Secondary Outcome Measure Information:
Title
To determine if clear cell renal malignancies can be predicted, or differentiated, from other less aggressive malignant subtypes, based on analysis of the data.
Time Frame
conclusion of study
Title
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
Time Frame
conclusion of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Gerst, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center
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Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast
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