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Completed

NCT Number: NCT02370290

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

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.

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Key information

Conditions

Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

medical chart review

Other

Clinical and imaging information collected

Other names: Chart Review

Informational intervention

Other

Clinical and imaging data collected

Primary outcomes

  1. 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).

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

    Time frame: Baseline

    Examined using weighted kappa coefficient.

  3. 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.

  4. Agreement between QIM predicted and clinical determined postoperative eGFR

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 24, 2015
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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