An observational study in Renal Cell Carcinoma, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-03.
Sponsored by University of Southern California · Observational
This pilot research trial studies quantitative imaging metrics derived from contrast enhanced computed tomography (CECT) in enhancing assessment of disease status in patients with kidney cancer. Quantitative imaging is the extraction of quantifiable features from radiological images for the assessment of disease status. Collecting quantitative imaging metrics from CECT imaging may help doctors predict tumor aggressiveness and nuclear grade (tumor stage) and assess treatment response and prognosis in cancer imaging.
PRIMARY OBJECTIVES:
I. To investigate the role of quantitative imaging metrics (QIM) as a potential DIAGNOSTIC biomarker.
II. To investigate if QIM parameters can differentiate clear cell renal cell carcinoma (RCC) from papillary RCC.
III. To evaluate the tumor grade of the target lesion as assessed by QIM from CECT for agreement with the pathological (Fuhrman) grade.
IV. To investigate the role of QIM as a potential PROGNOSTIC biomarker. V. To develop a novel method of calculating renal tumor contact surface area (CSA) using advanced image-processing technology (MATLAB®, 3 dimension [D] Synapse) and predict peri-operative variables such as blood loss, operative time and post-operative estimated glomerular filtration rate (eGFR) in patients undergoing partial nephrectomy (PN).
VI. To develop QIM that would help in predicting postoperative functional outcomes such as predicted surgically resected volume and postoperative glomerular filtration rate (GFR).
OUTLINE:
Patients' clinical and imaging data are collected from routine multiphase CECT imaging and used to establish and validate the classification/prediction rule for QIM.
1,966 studies on the registry are indexed under Carcinoma, Renal Cell; 378 are open to participants now.
This study's enrollment of 74 is below the median of 146 across 360 observational studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients' clinical and imaging data from the University of Southern California/Norris Comprehensive Cancer Center and Keck Hospital.
Exclusion Criteria:
Patients' clinical and imaging data are collected from routine multiphase CECT imaging and used to establish and validate the classification/prediction rule for QIM.
Other: Medical Chart Review · Other: Informational Intervention
Clinical and imaging information collected
Also known as: Chart Review
Clinical and imaging data collected
Agreement between QIM predicted and pathologically determined tumor class (clear cell renal cell carcinoma [ccRCC] vs papillary [p]RCC)
Cohen's kappa coefficient will be used to examine the agreement between QIM predicted and pathologically determined tumor class (ccRCC vs. pRCC).
Time frame: Baseline
Agreement between QIM predicted and pathologically determined tumor (Fuhrman) grade
Examined using weighted kappa coefficient.
Time frame: Baseline
Agreement between QIM predicted and clinically observed perioperative measurements such as blood loss, operative time, and eGFR
Examined using two-way random single measure with absolute agreement.
Time frame: Baseline
Agreement between QIM predicted and clinical determined postoperative eGFR
Examined using two-way random single measure with absolute agreement.
Time frame: Baseline
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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University of Southern California