Perfusion CT in Predicting Response to Treatment in Patients With Advanced Kidney Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01926990
First received: August 19, 2013
Last updated: August 19, 2014
Last verified: August 2014
  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 chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.


Condition Intervention
Recurrent Renal Cell Cancer
Stage III Renal Cell Cancer
Stage IV Renal Cell Cancer
Drug: perfusion
Procedure: computed tomography
Other: laboratory biomarker analysis

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Prediction of Response to Treatment in Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Changes in CT perfusion of the RCC lesions based on blood flow [ Time Frame: Baseline to up to 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Changes in CT perfusion of the RCC lesions based on blood volume [ Time Frame: Baseline to up to 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Changes in CT perfusion of the RCC lesions based on mean transit time [ Time Frame: Baseline to up to 12 weeks ] [ Designated as safety issue: No ]
    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.


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


Estimated Enrollment: 15
Study Start Date: August 2014
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (perfusion CT)
Patients undergo perfusion CT at baseline, 7 days, and 12 weeks.
Drug: perfusion
Undergo perfusion CT
Procedure: computed tomography
Undergo perfusion CT
Other Name: tomography, computed
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. Early prediction of response to treatment by correlating changes in quantitative perfusion CT with circulating tumor cells after 1 week of targeted therapy.

SECONDARY OBJECTIVES:

I. Demonstrate quantitative perfusion CT characteristics can predict early response to targeted therapeutics in patients with advanced renal cell carcinoma (RCC).

II. Correlate CT results with circulating tumor cells (circulating tumor cells [CTC] collection and analysis covered under separate protocol, e-protocol 12597) to predict response to targeted therapies (TT) in advanced RCC.

OUTLINE:

Patients undergo perfusion CT at baseline, 7 days, and 12 weeks.

After completion of study, patients are followed up for 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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: Aya Kino    312-404-1052    Akino2@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: August 19, 2014
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 September 22, 2014