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

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ClinicalTrials.gov Identifier: NCT03552497
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborators:
University of California, San Francisco
Stanford University
Erasmus Medical Center
Memorial Sloan Kettering Cancer Center
University of Sao Paulo General Hospital
University Hospital, Aachen
Information provided by (Responsible Party):
Maastricht University

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.


Condition or disease Intervention/treatment
Renal Cyst Complex Diagnostic Test: Radiomics

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Potential of Radiomics to Differentiate Between Malignant and Benign Bosniak 3 Renal Cysts.
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Radiomics
    The high-throughput extraction of large amounts of quantitative image features from radiographic medical images


Primary Outcome Measures :
  1. malignancy classifier [ Time Frame: 1 year ]
    Machine learning algorithm that can differentiate between malignant and beingn bosniak 3 renal cysts.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with renal cysts classified as bosniak 3 in one of the collaborating institutes.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552497


Contacts
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Contact: Henry Woodruff, PhD 0031615131998 h.woodruff@Maastrichtuniversity.nl
Contact: Abdalla Ibrahim, M.D 0031619386546 a.ibrahim@maastrichtuniversity.nl

Locations
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Netherlands
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6200 MD
Contact: Razvan Miclea, MD       razvan.miclea@mumc.nl   
Sponsors and Collaborators
Maastricht University
University of California, San Francisco
Stanford University
Erasmus Medical Center
Memorial Sloan Kettering Cancer Center
University of Sao Paulo General Hospital
University Hospital, Aachen

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Responsible Party: Maastricht University
ClinicalTrials.gov Identifier: NCT03552497     History of Changes
Other Study ID Numbers: BIIIP_18
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maastricht University:
Radiomics
Bosniak classification
Renal cell carcinoma
Medical imaging
Additional relevant MeSH terms:
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Cysts
Kidney Diseases, Cystic
Neoplasms
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases