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Clinical Trials/NCT02370290
NCT02370290
Completed
Not Applicable

CT Metrology: Quantitative Imaging Metrics With Advanced Visualization Tools for Cancer Imaging

University of Southern California1 site in 1 country74 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Cell Carcinoma
Sponsor
University of Southern California
Enrollment
74
Locations
1
Primary Endpoint
Agreement between QIM predicted and clinically observed perioperative measurements such as blood loss, operative time, and eGFR
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
February 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Subjects with a renal mass who are scheduled for surgery for presumed RCC
  • Subjects scheduled for standard of care contrast enhanced CT examination at USC Norris Comprehensive Cancer Center
  • Subjects competent to sign study specific written informed consent

Exclusion Criteria

  • Subjects who are pregnant
  • Subjects who cannot consent for themselves

Outcomes

Primary Outcomes

Agreement between QIM predicted and clinically observed perioperative measurements such as blood loss, operative time, and eGFR

Time Frame: Baseline

Examined using two-way random single measure with absolute agreement.

Agreement between QIM predicted and pathologically determined tumor (Fuhrman) grade

Time Frame: Baseline

Examined using weighted kappa coefficient.

Agreement between QIM predicted and pathologically determined tumor class (clear cell renal cell carcinoma [ccRCC] vs papillary [p]RCC)

Time Frame: Baseline

Cohen's kappa coefficient will be used to examine the agreement between QIM predicted and pathologically determined tumor class (ccRCC vs. pRCC).

Agreement between QIM predicted and clinical determined postoperative eGFR

Time Frame: Baseline

Examined using two-way random single measure with absolute agreement.

Study Sites (1)

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