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

NCT03552497 | Unknown DMC

• 1 other identifier: BIIIP_18
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Cyst Complex

Keywords

Radiomics; Bosniak classification; Renal cell carcinoma; Medical imaging

Outcome Measures

Primary Outcomes (1)

• malignancy classifier

  Machine learning algorithm that can differentiate between malignant and beingn bosniak 3 renal cysts.

  1 year

Interventions

Radiomics DIAGNOSTIC_TEST

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• CT-Scans that are reformatted or secondary.

Sponsors & Collaborators

• Maastricht University: lead
• University of California, San Francisco: collaborator
• Stanford University: collaborator
• Erasmus Medical Center: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• University of Sao Paulo General Hospital: collaborator
• University Hospital, Aachen: collaborator

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6200 MD, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Radiomics

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 12, 2018
• Study Start: August 7, 2018
• Primary Completion: December 1, 2020
• Study Completion: January 31, 2021
• Last Updated: April 6, 2020

Record last verified: 2020-04

Locations

NL (1)