Vascular Endothelial Growth Factor (VEGF) Imaging Before and During Everolimus Treatment for Renal Cell Carcinoma (Everolimage)

This study has been completed.
Information provided by (Responsible Party):
S.F. Oosting, University Medical Centre Groningen Identifier:
First received: December 8, 2009
Last updated: January 27, 2015
Last verified: January 2015

Everolimus indirectly inhibits angiogenesis by reducing VEGF production. VEGF can be non-invasively visualized and quantified with serial 89Zr-bevacizumab PET imaging in patients.

The investigators hypothesize that a decline in VEGF early during everolimus treatment in patients with metastatic renal cell carcinoma predicts treatment efficacy.

89Zr-bevacizumab PET scans will be performed at baseline, after 2 and 6 weeks of everolimus treatment in 14 adult patients with metastatic renal cell carcinoma.

Condition Intervention
Metastatic Renal Cell Carcinoma
Other: 89Zr-bevacizumab PET scan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 89Zr-bevacizumab PET Imaging in Patients With Renal Cell Carcinoma Treated With Everolimus; a Pilot Study

Resource links provided by NLM:

Further study details as provided by University Medical Center Groningen:

Primary Outcome Measures:
  • Change in 89Zr-bevacizumab uptake in tumor lesions between the baseline scan and the scan during treatment [ Time Frame: Baseline, 2 weeks and 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progressive disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, after 3 months of treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
whole blood, white blood cells, plasma, serum, urine

Enrollment: 13
Study Start Date: December 2009
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Renal Cancer
Renal Cancer patients treated with everolimus
Other: 89Zr-bevacizumab PET scan

A tracer dose of 89Zr-bevacizumab (37 MBq, 5 mg protein dose) is given intravenously at day -3, day 11 and day 39.

PET scans are made on day 1, day 15 and day 43.

Other Name: VEGF imaging

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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with metastatic renal cell carcinoma who will start treatment with everolimus.

Inclusion Criteria:

  • metastatic renal cell cancer
  • Intention to start treatment with everolimus
  • WHO performance score ≤ 2
  • 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
  • ≥ 18 years
  • 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

Exclusion Criteria:

  • formulated as "not" or "absence of" under inclusion criteria
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Please refer to this study by its identifier: NCT01028638

University Medical Centre Groningen
Groningen, Netherlands, 9700 RB
Sponsors and Collaborators
University Medical Center Groningen
Principal Investigator: Sjoukje Oosting, MD University Medical Center Groningen
  More Information

No publications provided

Responsible Party: S.F. Oosting, Principal investigator, University Medical Centre Groningen Identifier: NCT01028638     History of Changes
Other Study ID Numbers: NL28799.042.09, METc2009.236
Study First Received: December 8, 2009
Last Updated: January 27, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Center Groningen:
VEGF imaging
renal cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Endothelial Growth Factors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 25, 2015