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

Stanford University1 site in 1 country19 target enrollmentAugust 2014

ConditionsMetastatic Renal Cell Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Metastatic Renal Cell Cancer
Sponsor: Stanford University
Enrollment: 19
Locations: 1
Primary Endpoint: Characterization of the relationship between Change in blood flow measured through perfusion CT techniques and Change in tumor size measured through non-investigational CT
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

December 17, 2021

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Characterization of the relationship between Change in blood flow measured through perfusion CT techniques and Change in tumor size measured through non-investigational CT

Time Frame: 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication

Secondary Outcomes

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)