Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Stanford University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01926990
First received: August 19, 2013
Last updated: April 21, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention
Metastatic Renal Cell Cancer
Procedure: perfusion computed tomography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing Non-Invasive Early Therapeutic Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: August 2014
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: perfusion computed tomography
    Undergo perfusion CT
    Other Name: tomography, computed
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with metastatic renal cell carcinoma prescribed a systemic targeted therapy medication
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926990

Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Yoriko Imae    650-498-5186    yori@stanford.edu   
Principal Investigator: Aya Kamaya         
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Aya Kamaya Stanford University Hospitals and Clinics
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01926990     History of Changes
Other Study ID Numbers: RENAL0026  NCI-2013-01626  P30CA124435 
Study First Received: August 19, 2013
Last Updated: April 21, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 28, 2016