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Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01926990
Recruitment Status : Suspended (Business decision)
First Posted : August 21, 2013
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date August 19, 2013
First Posted Date August 21, 2013
Last Update Posted Date December 11, 2018
Study Start Date August 2014
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 15, 2015)
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 ]
Original Primary Outcome Measures
 (submitted: August 19, 2013)
Changes in CT perfusion of the RCC lesions based on calculated perfusion values for lesions such as blood flow, blood volume, mean transit time [ Time Frame: Baseline to up to 12 weeks ]
All statistical testing will be two-sided with a 5% significance level. To analyze significance of possible predictive biomarkers, odds ratios with 95% confidence intervals will be calculated for response to treatment. Receiver Operating Characteristics (ROC) will be calculated for continuous measurements.
Change History Complete list of historical versions of study NCT01926990 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 15, 2015)
  • Characterization of the relationship between change in perfusion CT measurements (eg. Mean transit time) and change in tumor size measured by non-investigational CT [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 weeks after start of standard systemic targeted therapy medication ]
Original Secondary Outcome Measures
 (submitted: August 19, 2013)
  • Progression free survival, defined as when the target lesion does not increase in size and does not increase in perfusion characteristics on CT perfusion using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From treatment to progression of disease or death, assessed up to 6 months ]
    All statistical testing will be two-sided with a 5% significance level. Hazards ratios with 95% confidence intervals will be calculated for progression free survival. ROC will be calculated for continuous measurements.
  • Overall response, measured using RECIST criteria [ Time Frame: Up to 1 year ]
    All statistical testing will be two-sided with a 5% significance level. Hazards ratios with 95% confidence intervals will be calculated for progression free survival. ROC will be calculated for continuous measurements.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects with metastatic renal cell carcinoma prescribed a systemic targeted therapy medication
Condition Metastatic Renal Cell Cancer
Intervention Device: perfusion computed tomography
Undergo perfusion CT
Other Name: tomography, computed
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Actual Enrollment
 (submitted: December 7, 2018)
19
Original Estimated Enrollment
 (submitted: August 19, 2013)
15
Estimated Study Completion Date July 2019
Actual Primary Completion Date July 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01926990
Other Study ID Numbers RENAL0026
NCI-2013-01626 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA124435 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Stanford University
Study Sponsor Stanford University
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Aya Kamaya Stanford University Hospitals and Clinics
PRS Account Stanford University
Verification Date December 2018