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

August 31, 2020 updated by: University of Kansas Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasonography
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
Diagnostic test: Ultrasonography
Abdominal Ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility of Renal Ultrasonography (US) in the detection of abdominal recurrences
Time Frame: 4 weeks
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Burden
Time Frame: 5 years
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2020

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 2, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00145327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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