Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01926990
First received: August 19, 2013
Last updated: May 15, 2015
Last verified: May 2015
  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
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:

  • Patients with suspected or biopsy-proven renal cell carcinoma
  • Patients who have undergone prior chemotherapy more than one year prior to the study are eligible for enrollment
  • Patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant
  • No life expectancy restrictions
  • Eastern Cooperative Oncology Group (ECOG) and Karnofsky performance status will not be employed
  • Patients with renal failure are ineligible for this study (glomerular filtration rate [GFR] must be > 45)
  • Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

  • No restrictions regarding use of other investigational agents
  • Patients with renal failure or contrast agent allergy will be excluded from the study
  • Patients with severe contrast allergy are ineligible
  • Patients who are pregnant or are trying to become pregnant are excluded from this study
  • Patients who are cancer survivors or human immunodeficiency virus (HIV)-positive will not be excluded
  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: Jenna Dauriac    650-736-0697    jdauriac@stanford.edu   
Principal Investigator: Aya Kamaya         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Aya Kamaya Stanford University Hospitals and Clinics
  More Information

No publications provided

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: May 15, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 30, 2015