Quantitative Imaging Metrics From CECT in Measuring Disease Response or Progression in Patients With Kidney Cancer

March 1, 2016 updated by: University of Southern California

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC Norris Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients' clinical and imaging data from the University of Southern California/Norris Comprehensive Cancer Center and Keck Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (QIM)
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
Clinical and imaging information collected
Other Names:
  • Chart Review
Other: Informational Intervention
Clinical and imaging data collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline
Agreement between QIM predicted and pathologically determined tumor (Fuhrman) grade
Time Frame: Baseline
Examined using weighted kappa coefficient.
Baseline
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.
Baseline
Agreement between QIM predicted and clinical determined postoperative eGFR
Time Frame: Baseline
Examined using two-way random single measure with absolute agreement.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Vinay Duddalwar, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 17, 2015

First Posted (Estimate)

February 24, 2015

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4K-13-2 (Other Identifier: USC Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH Grant/Contract)
  • NCI-2014-02547 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • HS-13-00256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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