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Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT01926990
Collaborator
Siemens Healthcare QT (Industry)
19
Enrollment
1
Location
88.5
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Device: perfusion computed tomography

Study Design

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 :
Aug 1, 2014
Actual Primary Completion Date :
Jul 16, 2018
Actual Study Completion Date :
Dec 17, 2021

Outcome Measures

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 [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 [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 [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 [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 [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 [12 weeks after start of standard systemic targeted therapy medication]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Stanford University Cancer Institute Stanford California United States 94305

Sponsors and Collaborators

  • Stanford University
  • Siemens Healthcare QT

Investigators

  • Principal Investigator: Aya Kamaya, Stanford University Hospitals and Clinics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stanford University
ClinicalTrials.gov Identifier:
NCT01926990
Other Study ID Numbers:
  • RENAL0026
  • NCI-2013-01626
First Posted:
Aug 21, 2013
Last Update Posted:
Feb 2, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Carcinoma, Renal Cell

Study Results

No Results Posted as of Feb 2, 2022