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Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

Developing Non-Invasive Early Therapeutic Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01926990
Enrollment
19
Registered
2013-08-21
Start date
2014-08-31
Completion date
2021-12-17
Last updated
2022-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Renal Cell Cancer

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.

Interventions

Undergo perfusion CT

Sponsors

Siemens Healthcare QT
CollaboratorINDUSTRY
Stanford University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Characterization of the relationship between Change in blood flow measured through perfusion CT techniques and Change in tumor size measured through non-investigational CT12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication

Secondary

MeasureTime frame
Characterization of the relationship between change in perfusion CT measurements (eg. Mean transit time) and change in tumor size measured by non-investigational CT12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication
Relationship between change in blood flow and tumor response measured on ordinal scale12 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 1212 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 survival12 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 size12 weeks after start of standard systemic targeted therapy medication

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026