Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-02547 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| HS-13-00256 | |||
| 4K-13-2 | Other Identifier | USC Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Chart Review | Other | Clinical and imaging information collected |
|
| Measure | Description | Time Frame |
|---|---|---|
| Agreement between QIM predicted and pathologically determined tumor class (clear cell renal cell carcinoma [ccRCC] vs papillary [p]RCC) | 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 | Examined using weighted kappa coefficient. | Baseline |
| Agreement between QIM predicted and clinically observed perioperative measurements such as blood loss, operative time, and eGFR | Examined using two-way random single measure with absolute agreement. | Baseline |
| Agreement between QIM predicted and clinical determined postoperative eGFR | Examined using two-way random single measure with absolute agreement. | Baseline |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients' clinical and imaging data from the University of Southern California/Norris Comprehensive Cancer Center and Keck Hospital.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vinay Duddalwar | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
Not provided
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
| Informational Intervention | Other | Clinical and imaging data collected |
|
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |