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Completed

NCT Number: NCT01926990

Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma

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.

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Key information

Conditions

Metastatic Renal Cell Cancer Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University Cancer Institute

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

perfusion computed tomography

Device

Undergo perfusion CT

Other names: tomography, computed

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

    Time frame: 12 weeks (+/- 5 days) after start of standard systemic targeted therapy medication

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Siemens Healthcare QT

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2021
First posted
Aug 21, 2013
Registry last updated
Feb 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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