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

NCT ID: NCT03552497

Last Updated: 2020-04-06

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

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-07

Study Completion Date

2021-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cyst Complex

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Radiomics

The high-throughput extraction of large amounts of quantitative image features from radiographic medical images

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role collaborator

University Hospital, Aachen

OTHER

Sponsor Role collaborator

Maastricht University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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BIIIP_18

Identifier Type: -

Identifier Source: org_study_id

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