The Potential of Radiomics to Differentiate Between Malignant and Benign Bosniak 3 Renal Cysts. (BIII)

April 3, 2020 updated by: Maastricht University

More than 200,000 new cases of renal cancer are diagnosed in the world each year, with more than 63,000 new cases in Europe alone. Of those, renal cell carcinoma (RCC) is the most common type in adults, making up more than 90% of the cases. Deciding on the benign or malignant nature of some RCC on the basis of medical images (CT, MRI, US) is an issue, which often leads to unnecessary surgery, morbidity and costs.

A categorization for renal cysts was introduced in the late 1980s known as the Bosniak classification. The Bosniak classification system classifies them into groups that are benign (I and II) and those that need surgical resection (III and IV), based on specific imaging features. However, defining the malignancy of category III lesions still remains a challenge. Though Bosniak classification for renal cysts is used worldwide and underwent a number of modifications, Bosniak III cysts still have almost a 1:1 chance of being malignant. So the problem is that approximately half of the Bosniak category III cystic lesions prove to be benign after surgery.

The proposed project aims to develop a quantitative image analysis (QIA) based multifactorial decision support system (mDSS) capable of classifying renal cysts with high accuracy into benign or malignant status, thus reducing the amount of unnecessary surgeries performed. Using standard-of-care CT images and clinical parameters, the customized DSS will then guide experts in planning a safe and effective diagnostic and treatment strategy for all RCC patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6200 MD
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with renal cysts classified as bosniak 3 in one of the collaborating institutes.

Description

Inclusion Criteria:

  • Patients who underwent contrast-enhanced CT-Scan, with radiological findings suggestive of Bosniak 3 renal cyst and have available results for pathology analysis of the cyst.

Exclusion Criteria:

  • CT-Scans that are reformatted or secondary.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
malignancy classifier
Time Frame: 1 year
Machine learning algorithm that can differentiate between malignant and beingn bosniak 3 renal cysts.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University

Collaborators

Memorial Sloan Kettering Cancer Center
University of Sao Paulo General Hospital
Erasmus Medical Center
University of California, San Francisco
Stanford University
University Hospital, Aachen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2018

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

January 31, 2021

Study Registration Dates

First Submitted

May 29, 2018

First Submitted That Met QC Criteria

May 29, 2018

First Posted (Actual)

June 12, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIIIP_18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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