Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 10 for:    stem cell kidney | ( Map: Netherlands )

Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00509704
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : November 9, 2010
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Radboud University

Brief 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.

Condition or disease
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Study on the Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma
Study Start Date : October 2008
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine






Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with a malignant abdominal tumor or metastases (minimal diameter 2 cm)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • contra-indications for MRI
  • contra-indications for treatment with Sunitinib
  • previous systemic treatment within the last 30 days

Information from the National Library of Medicine

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): NCT00509704


Locations
Layout table for location information
Netherlands
UMC St Radboud
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Novo Nordisk A/S
Investigators
Layout table for investigator information
Principal Investigator: C.M.L. van Herpen, MD, PhD UMC St Radboud

Layout table for additonal information
Responsible Party: C.M.L. van Herpen,, University Medical Centre Nijmegen, st Radboud
ClinicalTrials.gov Identifier: NCT00509704     History of Changes
Other Study ID Numbers: CMO 2006/232
First Posted: July 31, 2007    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: October 2010
Keywords provided by Radboud University:
Sutent
tumor necrosis
DCE-MRI (Dynamic enhanced magnetic resonance imaging)
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Pathologic Processes
Necrosis
Neovascularization, Pathologic
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases
Metaplasia
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action