Evaluating Renal Masses Using Ultrasound Intravenous Microbubble Contrast

Kidney Cancer Clinical Trial

Official title:

Evaluation of Renal Masses Using Ultrasound Intravenous Microbubble Contrast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671411
• Other study ID #: 07-165
• Status: Completed
• Phase: Phase 1
• First received: May 1, 2008
• Last updated: December 23, 2015
• Start date: March 2008
• Est. completion date: November 2011

Study information

• Verified date: December 2015
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 99 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms
• Renal Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the accuracy of contrast enhanced ultrasound of renal masses to predict benign vs. malignant histology		conclusion of study	No
Secondary	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	No
Secondary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center