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

NCT ID: NCT04424472

Last Updated: 2020-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-17

Study Completion Date

2022-12-01

Brief Summary

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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

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Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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

Study Groups

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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

Group Type EXPERIMENTAL

Ultrasonography

Intervention Type DIAGNOSTIC_TEST

Abdominal Ultrasonography

Interventions

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Ultrasonography

Abdominal Ultrasonography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Kansas Health System

Kansas City, Kansas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katherine Glavin

Role: CONTACT

913-588-8721

Other Identifiers

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STUDY00145327

Identifier Type: -

Identifier Source: org_study_id

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