Optical biopsy to improve the diagnosis of kidney cancer: a prospective, observational, multicentre, in-vivo study.

Phase 2

Completed

• Conditions: Kidney cancer; renal mass; 10038430

• Registration Number: NL-OMON39685
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 194

Inclusion Criteria

- Age >= 18 years
- Solid, enhancing mass on cross sectional imaging suspect for RCC
- Scheduled for nephrectomy, partial nephrectomy or cryoablation
- Signed informed consent

Exclusion Criteria

Patients with a renal mass that are not candidates for active treatment.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameter<br /><br>To determine the accuracy of OB to differentiate renal tumor pathology from<br /><br>benign tissue by means of minimal invasive quantitative optical coherence<br /><br>tomography and diffuse reflectance spectroscopy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters<br /><br>- To determine the differentiation capability of this combined technique to<br /><br>distinguish between the three most common RCC sub-types.<br /><br>- To determine whether OB is a good alternative to percutaneous biopsy for the<br /><br>diagnosing of renal cancer based upon accuracy and cost-effectiveness.</p><br>