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Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

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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

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.

Condition or disease Intervention/treatment
Metastatic Renal Cell Cancer Device: perfusion computed tomography

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing Non-Invasive Early Therapeutic Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma
Study Start Date : August 2014
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: perfusion computed tomography
    Undergo perfusion CT
    Other Name: tomography, computed


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926990


Locations
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United States, California
Stanford University Cancer Institute
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Aya Kamaya Stanford University Hospitals and Clinics

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01926990     History of Changes
Other Study ID Numbers: RENAL0026
NCI-2013-01626 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: August 21, 2013    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases