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Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00671411
First Posted: May 5, 2008
Last Update Posted: December 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
  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:

  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.

Condition Intervention Phase
Renal Cancer Kidney Cancer Drug: Ultrasound with intravenous microbubble contrast injection Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Renal Masses Using Ultrasound Intravenous Microbubble Contrast

Resource links provided by NLM:


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 ]

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 ]
  • 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 ]

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.
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.

  Eligibility

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00671411     History of Changes
Other Study ID Numbers: 07-165
First Submitted: May 1, 2008
First Posted: May 5, 2008
Last Update Posted: December 28, 2015
Last Verified: December 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
Ultrasound
07-165

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type