- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01926990
Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma
January 31, 2022 updated by: Stanford University
Developing Non-Invasive Early Therapeutic Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Stanford, California, United States, 94305
- Stanford University Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects with metastatic renal cell carcinoma prescribed a systemic targeted therapy medication
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication
|
12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication
|
Secondary Outcome Measures
Outcome Measure |
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
Time Frame: 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication
|
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
|
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
|
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
|
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
|
12 weeks after start of standard systemic targeted therapy medication
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Aya Kamaya, Stanford University Hospitals and Clinics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
July 16, 2018
Study Completion (Actual)
December 17, 2021
Study Registration Dates
First Submitted
August 19, 2013
First Submitted That Met QC Criteria
August 19, 2013
First Posted (Estimate)
August 21, 2013
Study Record Updates
Last Update Posted (Actual)
February 2, 2022
Last Update Submitted That Met QC Criteria
January 31, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RENAL0026
- NCI-2013-01626 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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