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

Not Applicable

• Conditions: Renal Cell Carcinoma
• Interventions: Diagnostic Test: Ultrasonography

• Registration Number: NCT04424472
• Lead Sponsor: University of Kansas Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-02
• Study First Submitted QC: 2020-06-05
• Study First Posted: 2020-06-11
• Study Start: 2020-07-17
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasonography	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

Primary Outcome Measures

Name	Time	Method
Utility of Renal Ultrasonography (US) in the detection of abdominal recurrences	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

Secondary Outcome Measures

Name	Time	Method
Radiation Burden	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

Trial Locations

Locations (1)

University of Kansas Health System; 🇺🇸 Kansas City, Kansas, United States