Kidney (Renal Cell) CancerNCT01326390
Impact of C-arm CT in Decreased Renal Function Undergoing TACE for Tx of Hepato-Cellular Carcinoma
An observational study of Kidney (Renal Cell) Cancer, run by Stanford University at 1 site in United States.
Trial summary
Impact on contrast dose or total volume of contrast required to effectively treat the targeted tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney (Renal Cell) Cancer
- What is being tested?
- dTA/dBA C-arm fluoroscopy system with Dyna CT, DSA arteriogram- hepatic arteries and CO2 aortogram
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jan 2012
- 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: All patients we are seeking will already have been scheduled to undergo liver Transhepatic arterial chemoembolizationWorld Health Organization treatment using C-arm CT as the imaging guidance (with limited Digital Subtraction angiography as needed).
Who may be able to join
- Patients must be affected by HCC
- Patients must have diminished renal function (GFR<60 ml/min/1.73m^2)
- Patients must be 18 years old or older
- Patients must have received an abdominal CT, PET/CT scan or MRI, completed prior to the TACE procedure.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects under the age of 18
- Patients currently on dialysis
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Impact of C-arm CT in Patients With Decreased Renal Function Undergoing Transhepatic Arterial Chemoembolization (TACE) for the Treatment of Hepato-Cellular Carcinoma
Impact on contrast dose or total volume of contrast required to effectively treat the targeted tumor.
- Conditions
- Kidney (Renal Cell) Cancer
- Being tested
- dTA/dBA C-arm fluoroscopy system with Dyna CT, DSA arteriogram- hepatic arteries, CO2 aortogram
- 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.
dTA/dBA C-arm fluoroscopy system with Dyna CTDevice
Also called X-ray image intensifier, Siemens Angiography systems
C-arm CT of the liver; state-of-the-art flat panel detector on a ceiling or floor mounted C-arm gantry
DSA arteriogram- hepatic arteriesProcedure or surgery
Also called Angiography, arteriography
Standard of care
CO2 aortogramProcedure or surgery
Also called Aortography
Standard of care
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that develop renal failure (defined as a decline of renal function, as measured by glomerular filtration rate, of 25% or more from pre-procedural)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startMay 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney (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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nishita N. Kothary, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326390
- Sponsor's protocol ID
- HEP0035
- Other IDs
- SU-07012010-6469
- Status last verified
- Jun 2016
- First submitted
- 6 Jul 2010
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of C-arm CT in Patients With Decreased Renal Function Undergoing Transhepatic Arterial Chemoembolization (TACE) for the Treatment of Hepato-Cellular Carcinoma
- ClinicalTrials.gov ID
- NCT01326390
- Acronym / sponsor ID
- HEP0035
- Conditions
- Kidney (Renal Cell) Cancer
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 30 Mar 2011 (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.
Impact on contrast dose or total volume of contrast required to effectively treat the targeted tumor.
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
- All patients we are seeking will already have been scheduled to undergo liver Transhepatic arterial chemoembolizationWorld Health Organization treatment using C-arm CT as the imaging guidance (with limited Digital Subtraction angiography as needed).
Key inclusion criteria (5 listed)
- Patients must be affected by HCC
- Patients must have diminished renal function (GFR<60 ml/min/1.73m^2)
- Patients must be 18 years old or older
- Patients must have received an abdominal CT, PET/CT scan or MRI, completed prior to the TACE procedure.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (3 listed)
- Subjects under the age of 18
- Patients currently on dialysis
- Pregnant women
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 |
|---|---|---|
| dTA/dBA C-arm fluoroscopy system with Dyna CTAlso: X-ray image intensifier, Siemens Angiography systemsC-arm CT of the liver; state-of-the-art flat panel detector on a ceiling or floor mounted C-arm gantry | Device | – |
| DSA arteriogram- hepatic arteriesAlso: Angiography, arteriographyStandard of care | Procedure or surgery | – |
| CO2 aortogramAlso: AortographyStandard of care | Procedure or surgery | – |
Primary outcome
Proportion of patients that develop renal failure (defined as a decline of renal function, as measured by glomerular filtration rate, of 25% or more from pre-procedural)
Time frame: 3 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
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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.
Nishita N. Kothary principal investigator
Stanford University
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 Kidney (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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 1 Jul 2016. 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 was stopped early. Results are not available in the source record.
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?
Proportion of patients that develop renal failure (defined as a decline of renal function, as measured by glomerular filtration rate, of 25% or more from pre-procedural) (time frame: 3 weeks). 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 1 Jul 2016.