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

This study has been completed.
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00509704
First received: July 30, 2007
Last updated: November 8, 2010
Last verified: October 2010
  Purpose

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
Renal Cell Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Estimated Enrollment: 10
Study Start Date: October 2008
Study Completion Date: May 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00509704

Locations
Netherlands
UMC St Radboud
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Novo Nordisk A/S
Investigators
Principal Investigator: C.M.L. van Herpen, MD, PhD UMC St Radboud
  More Information

No publications provided

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
Study First Received: July 30, 2007
Last Updated: November 8, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Sutent
tumor necrosis
DCE-MRI (Dynamic enhanced magnetic resonance imaging)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Necrosis
Neovascularization, Pathologic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Pathologic Processes
Metaplasia
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014