Renal Cell CancerNCT00509704
Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma
An observational study of Renal Cell Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The purpose of the study is to assess the effect of Sunitinib on tumor vascularization and necrosis in patients with metastatic renal cell cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Cancer
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2008to May 2010
- 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: Patients with a malignant abdominal tumor or metastases (minimal diameter 2 cm)
Who may be able to join
- patients with metastatic renal cell cancer for whom treatment with Sunitinib is planned
- histologically verified stage IV renal cell carcinoma of clear cell type
- measurable primary tumor or metastases (minimal diameter 2 cm) at other sites than the lungs
- Karnofsky score > 70%
- age > 18 year.
- written informed consent
Who cannot join
- contra-indications for MRI
- contra-indications for treatment with Sunitinib
- previous systemic treatment within the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma
The purpose of the study is to assess the effect of Sunitinib on tumor vascularization and necrosis in patients with metastatic renal cell cancer.
Read the detailed description
Sutent is an angiogenesis inhibitor used in the treatment of renal cell cancer. Very often tumor necrosis is seen after the start of the treatment. It is unknown after how many days this effect starts. In patients with renal cell cancer with metastases, who will be treated with Sutent, 3 MRIs will be made. Kep, R2*, b-coefficient (perfusion, hypoxia, blood volume and necrosis) will be measured.
- Conditions
- Renal Cell Cancer
- Keywords
- Sutent, tumor necrosis, DCE-MRI (Dynamic enhanced magnetic resonance imaging)
- Medical subject headings
- Carcinoma, Renal Cell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startOct 2008
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Investigators
- C.M.L. van Herpen, MD, PhD, Principal investigator, UMC St Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509704
- Sponsor's protocol ID
- CMO 2006/232
- Status last verified
- Oct 2010
- First submitted
- 30 Jul 2007
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00509704
- Acronym / sponsor ID
- CMO 2006/232
- Conditions
- Renal Cell Cancer
- Keywords
- Sutent, tumor necrosis, DCE-MRI (Dynamic enhanced magnetic resonance imaging)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Oct 2008
- Study completion
- May 2010 (actual)
- First posted
- 31 Jul 2007 (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.
The purpose of the study is to assess the effect of Sunitinib on tumor vascularization and necrosis in patients with metastatic renal cell cancer.
Detailed description
Sutent is an angiogenesis inhibitor used in the treatment of renal cell cancer. Very often tumor necrosis is seen after the start of the treatment. It is unknown after how many days this effect starts. In patients with renal cell cancer with metastases, who will be treated with Sutent, 3 MRIs will be made. Kep, R2*, b-coefficient (perfusion, hypoxia, blood volume and necrosis) will be measured.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a malignant abdominal tumor or metastases (minimal diameter 2 cm)
Key inclusion criteria (6 listed)
- patients with metastatic renal cell cancer for whom treatment with Sunitinib is planned
- histologically verified stage IV renal cell carcinoma of clear cell type
- measurable primary tumor or metastases (minimal diameter 2 cm) at other sites than the lungs
- Karnofsky score > 70%
- age > 18 year.
Key exclusion criteria (3 listed)
- contra-indications for MRI
- contra-indications for treatment with Sunitinib
- previous systemic treatment within the last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 9 Nov 2010.
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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.
C.M.L. van Herpen, MD, PhD principal investigator
UMC St Radboud
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 Renal Cell Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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 6 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: finished, as of the sponsor's last update on 9 Nov 2010. 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 Netherlands. 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.
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 9 Nov 2010.