Influence of Sutent on Tumor Vascularization and Necrosis... | NCT00509704

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

NCT00509704

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Nov 9, 2010Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Renal Cell Cancer

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Not provided

Completion Date

May 2010Actual

First Submitted Date

Jul 30, 2007

First Submission Date that Met QC Criteria

Jul 30, 2007

First Posted Date

Jul 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 8, 2010

Last Update Posted Date

Nov 9, 2010Estimated

Name	Class
Novo Nordisk A/S	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a malignant abdominal tumor or metastases (minimal diameter 2 cm)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
C.M.L. van Herpen, MD, PhD	UMC St Radboud	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UMC St Radboud		Nijmegen			Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided