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

NCT02440334 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 15P.039JT 7277
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Keywords

cryosurgery; ultrasonography

Outcome Measures

Primary Outcomes (1)

• The Sensitivity of Detecting RCC Recurrence (Using Contrast-enhanced MRI as a Reference Standard) on a Single Contrast-enhanced Ultrasound Exam.

  Patients scheduled for follow up contrast enhanced computed tomography (CT) or magnetic resonance imaging (MRI) of a previously cryoablatated renal cell carcinoma (RCC) through Thomas Jefferson University's Urology clinic will undergo a single ultrasound exam using contrast enhanced ultrasound. Ultrasound imaging will be performed using a state of the art ultrasound scanner with two and three dimensional curvilinear transducers.

  8 months post cryoblation

Study Arms (1)

Contrast Ultrasound Reccurence Screening

EXPERIMENTAL

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

Interventions

Optison DRUG

Optison is an ultrasound contrast agent. The agent is a blood pooling agent administered via catheter and provides improved ultrasound visualization of the vasculature.

Contrast Ultrasound Reccurence Screening

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Eisenbrey JR, Shaw CM, Lyshchik A, Machado P, Lallas CD, Trabulsi EJ, Merton DA, Fox TB, Liu JB, Brown DB, Forsberg F. Contrast-Enhanced Subharmonic and Harmonic Ultrasound of Renal Masses Undergoing Percutaneous Cryoablation. Acad Radiol. 2015 Jul;22(7):820-6. doi: 10.1016/j.acra.2015.03.008. Epub 2015 Apr 14.

  PMID: 25882093 RESULT

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

FS 069

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. John Eisenbrey
• Organization: Sidney Kimmel Cancer Center at Thomas Jefferson University

john.eisenbrey@jefferson.edu

(215) 503-5188

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 12, 2015
• Study Start: April 23, 2015
• Primary Completion: December 1, 2017
• Study Completion: June 21, 2018
• Last Updated: May 4, 2025
• Results First Posted: April 30, 2019

Record last verified: 2025-05

Locations

US (1)