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Contrast-Enhanced Ultrasound in Predicting Treatment Response in Patients With Kidney Cancer Undergoing Cryosurgery

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ClinicalTrials.gov Identifier: NCT02671552
Recruitment Status : Withdrawn (Terminated by the IRB)
First Posted : February 2, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University ( Sidney Kimmel Cancer Center at Thomas Jefferson University )

Brief Summary:
This pilot clinical trial compares the imaging results of contrast-enhanced ultrasound to contrast-enhanced magnetic resonance imaging (MRI) or computed tomography (CT), the current clinical standard, in predicting treatment response in patients with kidney cancer undergoing cryosurgery (a procedure in which an extremely cold liquid or an instrument called a cryoprobe is used to freeze and destroy abnormal tissue). Using contrast-enhanced ultrasound that does not involve a dye may help patients avoid side effects from a dye that is usually used in MRI or CT and may help doctors measure blood flow and determine whether the cryosurgery procedure treated the kidney tumor.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Perflutren Protein-Type A Microspheres Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging Early Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. Evaluate if contrast-enhanced ultrasound can be used to successfully evaluate the cryoablation (cryosurgery) of renal cell carcinoma.

SECONDARY OBJECTIVES:

I. Establish whether contrast-enhanced ultrasound provides a reliable tool for the characterization of renal masses prior to cryoablation.

TERTIARY OBJECTIVES:

I. Compare harmonic imaging (the current industry standard for contrast imaging) with subharmonic imaging (a novel, improved contrast imaging technique) in the two aims listed above.

OUTLINE:

Patients receive perflutren protein-type A microspheres intravenously (IV) and then undergo contrast-enhanced ultrasound imaging the morning prior to cryosurgery and at 3-4 months post treatment during MRI or CT follow up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Contrast-Enhanced Ultrasound for the Evaluation of Renal Cell Carcinoma Cryoablation
Actual Study Start Date : January 24, 2013
Actual Primary Completion Date : December 4, 2014
Actual Study Completion Date : December 4, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
Drug Information available for: Perflutren

Arm Intervention/treatment
Experimental: Diagnostic (contrast-enhanced ultrasound)
Patients receive perflutren protein-type A microspheres IV and then undergo contrast-enhanced ultrasound imaging the morning prior to cryosurgery and at 3-4 months post treatment during Magnetic Resonance Imaging (MRI) or computed tomography (CT) follow up.
Drug: Perflutren Protein-Type A Microspheres
Given IV
Other Name: Optison, Perflutren Protein-Type A Microspheres

Procedure: Dynamic Contrast-Enhanced Ultrasound Imaging
Undergo contrast-enhanced ultrasound imaging




Primary Outcome Measures :
  1. Sensitivity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma [ Time Frame: Up to 3-4 months after cryosurgery ]
    Sensitivity will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.

  2. Specificity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma [ Time Frame: Up to 3-4 months after cryosurgery ]
    Specificity will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.

  3. Accuracy - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma [ Time Frame: Up to 3-4 months after cryosurgery ]
    Accuracy will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.

  4. Positive predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma [ Time Frame: Up to 3-4 months after cryosurgery ]
    Positive predictive value will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.

  5. Negative predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma [ Time Frame: Up to 3-4 months after cryosurgery ]
    Negative predictive value will be calculated for the contrast-enhanced ultrasound exam using both the standard of care contrast-enhanced CT or MRI, and patient outcome as the reference standard. Correlations between these findings and both contrast-enhanced MRI or CT findings and patient outcomes will be compared using the Fisher exact test.


Secondary Outcome Measures :
  1. Sensitivity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma [ Time Frame: Up to 3-4 months after cryosurgery ]
    Inter- and intra-observer variability will be calculated.

  2. Specificity - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma [ Time Frame: Up to 3-4 months after cryosurgery ]
    Inter- and intra-observer variability will be calculated.

  3. Positive predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma [ Time Frame: Up to 3-4 months after cryosurgery ]
    Inter- and intra-observer variability will be calculated.

  4. Negative predictive value - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma [ Time Frame: Up to 3-4 months after cryosurgery ]
    Inter- and intra-observer variability will be calculated.

  5. Accuracy - Ability of contrast-enhanced ultrasound to successfully evaluate the cryoablation of renal cell carcinoma [ Time Frame: Up to 3-4 months after cryosurgery ]
    Inter- and intra-observer variability will be calculated.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be scheduled for a percutaneous cryoablation of a renal mass
  • Be medically stable
  • If a female of child-bearing potential, must have a negative pregnancy test
  • Have signed informed consent to participate in the study

Exclusion Criteria:

  • Females who are pregnant or nursing
  • Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:

    • Patients on life support or in a critical care unit
    • Patients with unstable occlusive disease (eg, crescendo angina)
    • Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
    • Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)
  • Patients with recent cerebral hemorrhage
  • Patients with known sensitivities to albumin, blood, or blood products
  • Patients who have undergone surgery within 24 hours prior to the study sonographic examination
  • Patients with known hypersensitivity to perflutren
  • Patients who have received any contrast medium (X-ray, MRI, CT, or ultrasound [US]) in the 24 hours prior to the research US exam
  • Patients with cardiac shunts
  • Patients with congenital heart defects
  • Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
  • Patients with respiratory distress syndrome
  • Patients with renal insufficiency such that they can not get intravenous contrast as part of screening or follow-up

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): NCT02671552


Locations
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United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Sidney Kimmel Cancer Center at Thomas Jefferson University
Investigators
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Principal Investigator: Flemming Forsberg, PhD Thomas Jefferson University
Additional Information:
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Responsible Party: Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02671552    
Other Study ID Numbers: 12P.615
2012-84 ( Other Identifier: Thomas Jefferson University )
NCI-2015-01470 ( Registry Identifier: NCI Clinical Trials Reporting Program )
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases