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Two and Three Dimensional Contrast-enhanced Ultrasound for Screening of Renal Cell Carcinoma Recurrence Following Cryoablation

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ClinicalTrials.gov Identifier: NCT02440334
Recruitment Status : Unknown
Verified October 2016 by john eisenbrey, Thomas Jefferson University.
Recruitment status was:  Recruiting
First Posted : May 12, 2015
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
john eisenbrey, Thomas Jefferson University

Brief Summary:
The purpose of the proposed trial is to determine whether contrast-enhanced ultrasound (CEUS) can be used to assess the recurrence of renal cell carcinoma (RCC) after cryoablation compared to contrast enhanced CT or MR (the standard evaluation). This study involves the off-label use of an FDA-approved ultrasound contrast agent, Optison that flows in the vascularity. CEUS will be performed by both two and three dimensional ultrasound to examine post-cryoablation vascularity changes to screen for recurrent disease.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Optison Phase 2

Detailed Description:

Subjects eligible for trial enrollment will be identified by the Thomas Jefferson University Urology group from their patient population of subjects under active surveillance for recurrence of a previously cryoablated RCC. A research coordinator will explain the study to the patient. The patient will be given time to consider the risks and benefits of the study and ask questions about participation. The coordinator will review the consent form with the patient and then the patient will be given the form to review. The patient, coordinator, and a study investigator will all sign the consent form. The patient will be given a copy of the signed consent form for their records.

Screening assessments will be performed prior to CEUS imaging. Trial participants will have the presence of inclusion criteria and absence of exclusion criteria verified by providing a medical history. A full demographic profile, known drug allergies or intolerances, and a review of the subject's medical/surgical history will be recorded. If the subject is a woman of childbearing age, she will have a urine pregnancy test (the results of which will be made available to the subject prior to study initiation).

All contrast injections will be supervised by a board certified physician. Resuscitation equipment and trained personnel will be in immediate proximity to the patient during each CEUS exam. The ultrasound examinations will be performed by a qualified sonographer. Ultrasound exams will take place the morning prior to the patient's 8, 12, 18, 24, or 36 month CT/MRI follow up (scheduled as part of their clinical care) or during their consultation in Jefferson's Urology clinic (for patients who have imaging performed outside Jefferson). Procedures and equipment for this trial will be used in accordance with typical clinical procedures. All trial procedures will be conducted in accordance with Good Clinical Practice. For the ultrasound examination, the patient will be asked to lie in the supine position and a catheter will be placed in a superficial vein (preferably an antecubital vein). Acoustic coupling gel will be applied to the area of interest. A state of the art ultrasound scanner with 2D and 3D curvilinear probes will be used.

A baseline ultrasound grayscale scan will be used to identify the tumor and to evaluate the following criteria: size, shape, and orientation of the lesion; echogenicity compared to surrounding tissue. Standard power Doppler of the lesion will also be performed. When possible, previous MR/CT data will be uploaded onto the scanner in order to perform image fusion for ultrasound guidance during imaging. The distribution of color signals and the overall color content of the tumor will be evaluated by comparing the pattern and amount of color to the normal surrounding tissue. Following baseline scanning, patients will receive a 1 ml intravenous injection of Optison (GE Healthcare, Princeton, NJ) in a peripheral vein followed by renal mass imaging in 2D CHI (a nonlinear contrast imaging package). Ten minutes after the 2D CEUS exam, patients will receive a second bolus injection of Optison followed by 3D CHI (using a curvilinear 3D array). All contrast injections will be supervised by a board certified physician. Resuscitation equipment and trained personnel will be immediate proximity to the patient during each contrast-enhanced ultrasound exam. Digital clips of the exams will be recorded through the contrast agent wash-in and wash-out phases for at least two minutes and stored for later use. The subject will then be monitored for adverse reactions for 30 minutes. If the patient wishes to continue participating in the study, they will be eligible for CEUS exams during their future clinically scheduled follow up exams as long as these take place within the study timeframe.

Patients will be monitored for AEs during and 30 minutes after contrast administration. All other procedures will be performed according to standard of care. No further patient monitoring is required as side effects of Optison are acute in nature and no renal toxicity has been reported.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : May 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Contrast Ultrasound Reccurence Screening
Patients scheduled for MRI/CT follow up of a renal cancer previously treated by cryoablation therapy who will also undergo a contrast-enhanced ultrasound exam. This is a one-time imaging study and contrast ultrasound exams will be compared to the clinically scheduled MRI/CT.
Drug: Optison
Optison is an ultrasound contrast agent. The agent is a blood pooling agent administered via catheter and provides improved ultrasound visualization of the vasculature.




Primary Outcome Measures :
  1. Identification of renal cell carcinoma recurrence [ Time Frame: Day of study ]


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:

  • Previously received cryotherapy of RCC.
  • Be scheduled for contrast-enhanced MRI/CT to monitoring of RCC recurrence as part of their 8, 12, 18, 24, or 36 month CT/MRI follow up.
  • Be at least 18 years of age.
  • Be medically stable.
  • If a female of child-bearing age, 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 (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 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.

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): NCT02440334


Contacts
Contact: John R Eisenbrey, PhD (215) 503-5188 john.eisenbrey@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: John R Eisenbrey, PhD    215-503-5188    john.eisenbrey@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University

Publications of Results:
Responsible Party: john eisenbrey, Research Assistant Professor, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02440334     History of Changes
Other Study ID Numbers: 15P.039
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by john eisenbrey, Thomas Jefferson University:
cryosurgery
ultrasonography

Additional relevant MeSH terms:
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