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Assessing the Utility of Ultrasound Compared to Cross-Sectional Imaging in the Follow-up of Patients With Renal Cell Carcinoma

Primary Purpose

Renal Cell Carcinoma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasonography
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients must be 18 year of age or older.
  • Patients having undergone radical or partial nephrectomy for the indication of renal cell carcinoma.
  • Most recent imaging study must have been either computed tomography (CT) or magnetic resonance imaging (MRI).

Exclusion Criteria:

  • Patients with pT4 disease (tumor invades beyond the Gerota fascia: including contiguous extension into the ipsilateral adrenal gland).
  • Patients with metastatic disease prior to time of surgery requiring systemic treatment.
  • Patients with another active cancer diagnosis requiring systemic treatment.
  • Patients with contrast allergies.
  • Patients with baseline chronic kidney disease (GFR < 45 ml/min/1.73 m2).

Sites / Locations

  • University of Kansas Health SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultrasonography

Arm Description

Patient will be scheduled to undergo an additional US by a blinded sonographer within 4 weeks of their most recent cross-sectional imaging that indicated a recurrence

Outcomes

Primary Outcome Measures

Utility of Renal Ultrasonography (US) in the detection of abdominal recurrences
Renal Cell Carcinoma (RCC) recurrence detection of ultrasonography in patients who have undergo definitive therapy for RCC compared to detection rate of cross-sectional imaging

Secondary Outcome Measures

Radiation Burden
Compare the average radiation exposure over 5 years for patients on current standard of care imaging surveillance for RCC, which consists of both ultrasound and cross-sectional imaging, to that of patients who would only receive cross-section imaging surveillance for RCC. This would yield overall increase in radiation burden for patients with RCC

Full Information

First Posted
June 2, 2020
Last Updated
August 31, 2020
Sponsor
University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04424472
Brief Title
Assessing the Utility of Ultrasound Compared to Cross-Sectional Imaging in the Follow-up of Patients With Renal Cell Carcinoma
Official Title
Assessing the Utility of Ultrasound Compared to Cross-Sectional Imaging in the Follow-up of Patients With Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 17, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to determine the utility of renal ultrasonography (US) in the detection of abdominal recurrences after definitive therapy for renal cell carcinoma (RCC) and compare the detection rate to that of cross-sectional imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The sonographer for the additional ultrasound will be blinded as will be the blinded radiology who will compare the US to the most recent negative CT/MRI to determine if recurrence is visualized by US
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasonography
Arm Type
Experimental
Arm Description
Patient will be scheduled to undergo an additional US by a blinded sonographer within 4 weeks of their most recent cross-sectional imaging that indicated a recurrence
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasonography
Intervention Description
Abdominal Ultrasonography
Primary Outcome Measure Information:
Title
Utility of Renal Ultrasonography (US) in the detection of abdominal recurrences
Description
Renal Cell Carcinoma (RCC) recurrence detection of ultrasonography in patients who have undergo definitive therapy for RCC compared to detection rate of cross-sectional imaging
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Radiation Burden
Description
Compare the average radiation exposure over 5 years for patients on current standard of care imaging surveillance for RCC, which consists of both ultrasound and cross-sectional imaging, to that of patients who would only receive cross-section imaging surveillance for RCC. This would yield overall increase in radiation burden for patients with RCC
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must be 18 year of age or older. Patients having undergone radical or partial nephrectomy for the indication of renal cell carcinoma. Most recent imaging study must have been either computed tomography (CT) or magnetic resonance imaging (MRI). Exclusion Criteria: Patients with pT4 disease (tumor invades beyond the Gerota fascia: including contiguous extension into the ipsilateral adrenal gland). Patients with metastatic disease prior to time of surgery requiring systemic treatment. Patients with another active cancer diagnosis requiring systemic treatment. Patients with contrast allergies. Patients with baseline chronic kidney disease (GFR < 45 ml/min/1.73 m2).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Glavin
Phone
913-588-8721
Email
kglavin@kumc.edu
Facility Information:
Facility Name
University of Kansas Health System
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing the Utility of Ultrasound Compared to Cross-Sectional Imaging in the Follow-up of Patients With Renal Cell Carcinoma

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