Clinical trial NCT01926990: Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma
Official title: Developing Non-Invasive Early Therapeutic Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Siemens Healthcare QT
First posted: 2013-08-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with metastatic renal cell carcinoma prescribed a systemic targeted therapy medication

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.


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

Primary outcomes:
measure: Characterization of the relationship between Change in blood flow measured through perfusion CT techniques and Change in tumor size measured through non-investigational CT
timeFrame: 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication
Secondary outcomes:
measure: Characterization of the relationship between change in perfusion CT measurements (eg. Mean transit time) and change in tumor size measured by non-investigational CT
timeFrame: 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication
measure: Relationship between change in blood flow and tumor response measured on ordinal scale
timeFrame: 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication
measure: 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
timeFrame: 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication
measure: Relationship between change in blood flow at Day 8 and at Week 12 and progression-free survival
timeFrame: 12 weeks after start of standard systemic targeted therapy medication
measure: Relationship between change in blood flow at Day 8 and at Week 12 and time to nadir of tumor size
timeFrame: 12 weeks after start of standard systemic targeted therapy medication
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Cancer Institute
state: California
Study officials:
affiliation: Stanford University Hospitals and Clinics
name: Aya Kamaya
role: PRINCIPAL_INVESTIGATOR
References: