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

NCT04424472 | Unknown

• 1 other identifier: STUDY00145327
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiation Burden

  5 years

Study Arms (1)

Ultrasonography

EXPERIMENTAL

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

Interventions

Ultrasonography DIAGNOSTIC_TEST

Abdominal Ultrasonography

Ultrasonography

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Health System

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Ultrasonography

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Katherine Glavin

CONTACT

913-588-8721; kglavin@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 11, 2020
• Study Start: July 17, 2020
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)