Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

Study Overview
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Brief Summary
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This pilot clinical trial studies perfusion computed tomography (CT) in predicting response to treatment in patients with advanced kidney cancer. Comparing results of diagnostic procedures done before, during, and after targeted therapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Official Title
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Developing Non-Invasive Early Therapeutic Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

Conditions
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Metastatic Renal Cell Cancer

Intervention / Treatment
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* Device: perfusion computed tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suspected or biopsy-proven renal cell carcinoma Treatment planned with sunitinib, pazopanib, sorafenib, bevacizumab, axitinib, nivolumab alone or in combination with an investigational agent Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: Serum creatinine greater than or equal to 1.7 mg/dL Severe allergy to contrast agent Any contraindication for undergoing a CT scan Pregnancy or unwillingness to use preventative measures if a woman of child-bearing potential

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: perfusion computed tomography|Undergo perfusion CT|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the relationship between Change in blood flow measured through perfusion CT techniques and Change in tumor size measured through non-investigational CT |  | 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the relationship between change in perfusion CT measurements (eg. Mean transit time) and change in tumor size measured by non-investigational CT |  | 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication | 
| Relationship between change in blood flow and tumor response measured on ordinal scale |  | 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication | 
| Relationship between change in blood flow at Day 8 and change in tumor size measured on continuous scale at Week 12 and tumor response measured on ordinal scale at Week 12 |  | 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication | 
| Relationship between change in blood flow at Day 8 and at Week 12 and progression-free survival |  | 12 weeks after start of standard systemic targeted therapy medication | 
| Relationship between change in blood flow at Day 8 and at Week 12 and time to nadir of tumor size |  | 12 weeks after start of standard systemic targeted therapy medication |