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

University of Southern California

Status: Completed

Conditions: Renal Cell Carcinoma

Treatments: Other: Medical Chart Review; Other: Informational Intervention

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02370290

NCI-2014-02547 (Registry Identifier)

4K-13-2 (Other Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

HS-13-00256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

74 participants in 1 patient group

Observational (QIM)

Description:

Patients' clinical and imaging data are collected from routine multiphase CECT imaging and used to establish and validate the classification/prediction rule for QIM.

Treatment:

Other: Medical Chart Review

Other: Informational Intervention