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

Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04424472
• Other study ID #: STUDY00145327
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2020
• Source: University of Kansas Medical Center
• Contact: Katherine Glavin
• Phone: 913-588-8721
• Email: kglavin[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Diagnostic Test:
• Ultrasonography
Abdominal Ultrasonography

Locations

Country	Name	City	State
United States	University of Kansas Health System	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks
Secondary	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	5 years