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Completed

NCT Number: NCT00671411

Evaluating 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.

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Key information

Conditions

Renal Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Cancer Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memorial Sloan-Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound with intravenous microbubble contrast injection

Drug

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.

Primary outcomes

  1. To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology

    Time frame: conclusion of study

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Evaluation of Renal Masses Using Ultrasound Intravenous Microbubble Contrast

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 5, 2008
Registry last updated
Dec 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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