Clinical trial NCT02370290: Quantitative Imaging Metrics From CECT in Measuring Disease Response or Progression in Patients With Kidney Cancer
Official title: CT Metrology: Quantitative Imaging Metrics With Advanced Visualization Tools for Cancer Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-02-24
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Agreement between QIM predicted and pathologically determined tumor class (clear cell renal cell carcinoma [ccRCC] vs papillary [p]RCC)
timeFrame: Baseline
measure: Agreement between QIM predicted and pathologically determined tumor (Fuhrman) grade
timeFrame: Baseline
measure: Agreement between QIM predicted and clinically observed perioperative measurements such as blood loss, operative time, and eGFR
timeFrame: Baseline
measure: Agreement between QIM predicted and clinical determined postoperative eGFR
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Vinay Duddalwar
role: PRINCIPAL_INVESTIGATOR
References: