Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast - Full Text View

Purpose

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.

Condition	Intervention	Phase
Renal Cancer Kidney Cancer	Procedure: Ultrasound with intravenous microbubble contrast injection	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Evaluation of Renal Masses Using Ultrasound Intravenous Microbubble Contrast

Resource links provided by NLM:

MedlinePlus related topics: Cancer Kidney Cancer

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

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. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	42
Study Start Date:	March 2008
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Procedure: 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.

Arms

Assigned Interventions

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.

Procedure: 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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671411

Locations

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

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Scott Gerst, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00671411 History of Changes
Other Study ID Numbers:	07-165
Study First Received:	May 1, 2008
Last Updated:	November 3, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Ultrasound
07-165

Additional relevant MeSH terms:

Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013