Metastatic Renal Cell CancerNCT01926990
Perfusion CT Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma
An observational study of Metastatic Renal Cell Cancer, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Cancer
- What is being tested?
- perfusion computed tomography
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 17 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with metastatic renal cell carcinoma prescribed a systemic targeted therapy medication
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Cancer Institute
Stanford, California, 94305
About this study
Official title: Developing Non-Invasive Early Therapeutic 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.
- Conditions
- Metastatic Renal Cell Cancer
- Being tested
- perfusion computed tomography
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perfusion computed tomographyDevice
Also called tomography, computed
Undergo perfusion CT
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the relationship between Change in blood flow measured through perfusion CT techniques and Change in tumor size measured through non-investigational CT
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 weeks after start of standard systemic targeted therapy medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startAug 2014
- Primary completion16 Jul 2018
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Healthcare QT
- Responsible party
- Sponsor
- Investigators
- Aya Kamaya, Principal investigator, Stanford University Hospitals and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926990
- Sponsor's protocol ID
- RENAL0026
- Other IDs
- NCI-2013-01626
- Status last verified
- Jan 2022
- First submitted
- 19 Aug 2013
- Last updated
- 2 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Non-Invasive Early Therapeutic Monitoring to Predict Treatment Efficacy in Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01926990
- Acronym / sponsor ID
- RENAL0026
- Conditions
- Metastatic Renal Cell Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Siemens Healthcare QT
- Study start
- Aug 2014
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 21 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with metastatic renal cell carcinoma prescribed a systemic targeted therapy medication
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perfusion computed tomographyAlso: tomography, computedUndergo perfusion CT | Device | – |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aya Kamaya principal investigator
Stanford University Hospitals and Clinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2022.