Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

Metastatic Renal Cell Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926990
• Other study ID #: RENAL0026
• Secondary ID: NCI-2013-01626
• Status: Completed
• Start date: August 2014
• Est. completion date: December 17, 2021

Study information

• Verified date: January 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 17, 2021
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Metastatic Renal Cell Cancer

Intervention

Device:
• perfusion computed tomography
Undergo perfusion CT

Locations

Country	Name	City	State
United States	Stanford University Cancer Institute	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Siemens Healthcare QT

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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