NCT01926990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
12 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2018

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2021

Completed
Last Updated

February 2, 2022

Status Verified

January 1, 2022

Enrollment Period

4 years

First QC Date

August 19, 2013

Last Update Submit

January 31, 2022

Conditions

Metastatic Renal Cell Cancer

Outcome Measures

Primary Outcomes (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 Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

perfusion computed tomographyDEVICE

Undergo perfusion CT

Also known as: tomography, computed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with metastatic renal cell carcinoma prescribed a systemic targeted therapy medication

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Cancer Institute

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Aya Kamaya

    Stanford University Hospitals and Clinics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

August 1, 2014

Primary Completion

July 16, 2018

Study Completion

December 17, 2021

Last Updated

February 2, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)