VEGF Imaging in Renal Cell Carcinoma | NCT00831857

Studies
VEGF Imaging in Renal Cell Carcinoma

NCT00831857

Sponsor

University Medical Center Groningen

Status

Completed

Last Update Posted

May 6, 2024Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Renal Cell Carcinoma

Interventions

89Zr-Bevacizumab PET-scan

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

May 2024

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

Jan 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jan 28, 2009

First Submission Date that Met QC Criteria

Jan 28, 2009

First Posted Date

Jan 29, 2009Estimated

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

May 3, 2024

Last Update Posted Date

May 6, 2024Actual

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 primary objective of the study is to evaluate the feasibility of 89Zr-bevacizumab PET imaging as a biomarker before and during treatment with sunitinib or bevacizumab plus interferon in patients with RCC. 89Zr-bevacizumab PET imaging will be regarded a promising biomarker if the target for treatment (VEGF) can be visualised and if uptake changes after institution of treatment.

Detailed Description

To explore if 89Zr-bevacizumab PET imaging can differentiate RCC patients with progressive disease from patients with non-progressive disease during treatment with sunitinib or bevacizumab plus interferon.
To explore relationships between VEGF pathway related biomarkers and 89Zr-bevacizumab PET response.
To explore effect of 2 weeks off treatment in the sunitinib arm on pharmacodynamic biomarkers and 89Zr-bevacizumab PET response.

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

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		Treatment with sunitinib.	Other: 89Zr-Bevacizumab PET-scan
Group B		Treatment with bevacizumab and interferon	Other: 89Zr-Bevacizumab PET-scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
89Zr-Bevacizumab PET-scan	Other	At baseline, after two weeks of treatment and after 6 weeks of treatment.	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint is the change in SUV between baseline 89Zr-bevacizumab PET scan and the scan performed after 2 and 6 weeks of treatment with sunitinib or bevacizumab plus interferon in patients with RCC.		after 2 and 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progression is defined as the appearance of new disease or an increase of 20% in the sum of the longest diameters of the target lesions.		3 months after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

locally advanced irresectable or metastatic renal cell cancer
no untreated brain metastases (CT or MRI not necessary in the absence of symptoms)
no uncontrolled hypertension
no clinically significant cardiovascular events or disease during the last 12 months
no surgery in the last 4 weeks
no treatment with bevacizumab or another monoclonal antibody with anti-angiogenic properties in the last 4 months
no treatment with a tyrosine kinase inhibitor during the last 4 weeks
measurable disease with x-ray or CT scan, at least one site of disease must be unidimensionally measurable as follows: X-ray > 20 mm, Spiral CT scan > 10 mm, non-spiral CT scan > 20 mm
clear cell histology component
not pregnant or nursing
women of childbearing potential must use effective contraception
absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
before patient randomization, written informed consent must be given according to GCP, and local regulations

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 locally advanced irresectable or metastatic renal cell cancer.

Sampling Method

Probability Sample

Name	Affiliation	Role
Sjoukje F. Oosting, MD	University Medical Center Groningen	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Groningen		Groningen		9700 RB	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

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Browse Branches

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