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

- Device: perfusion computed tomography
Undergo perfusion CTOther Name: tomography, computed
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 ]
- 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 |
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

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
United States, California | |
Stanford University Cancer Institute | |
Stanford, California, United States, 94305 |
Principal Investigator: | Aya Kamaya | Stanford University Hospitals and Clinics |
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 |
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 |
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 |