Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast

NCT00671411 | Completed Phase 1

• 1 other identifier: 07-165
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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:

1. 1.benign kidney masses can be distinguished from kidney cancers and
2. 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.

Conditions

Renal Cancer; Kidney Cancer

Keywords

Ultrasound; 07-165

Outcome Measures

Primary Outcomes (1)

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

  conclusion of study

Secondary Outcomes (2)

• 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

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

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.

Also known as: 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.

1

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

High-Energy Shock Waves; Congresses as Topic; Amino Acid Motifs

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Organizations; Health Care Economics and Organizations; Protein Structural Elements; Protein Conformation; Molecular Conformation; Molecular Structure; Biochemical Phenomena; Chemical Phenomena; Protein Structure, Secondary

Study Officials

• Scott Gerst, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 5, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 28, 2015

Record last verified: 2015-12

Locations

US (1)