89Zr-bevacizumab PET Imaging in Patients With Neuroendocrine Tumors

Sponsor
University Medical Center Groningen
Study ID
NCT01338090
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 89Zr-bevacizumab — DRUG
    Intravenous injection 120 MBq
  • Everolimus — DRUG
    Oral use, 10 mg per day

Study Details

This is a pilot study for evaluation of 89Zr-bevacizumab PET imaging as predictive biomarker during treatment with everolimus in patients with neuroendocrine tumors. Patients with progressive disease during the last year will receive treatment with everolimus 10 mg/day orally and 89Zr-bevacizumab PET imaging will be performed before start of treatment and after 2 and 12 weeks of treatment in the first three patients. If the scan after 2 weeks of treatment is already informative further patients will not undergo a scan at 12 weeks. A scan is considered already informative if both scans show at least 30% decrease in uptake in case of response, or at least 30% increase in uptake in case of disease progression. Four days before the scan patients will be injected intravenously 37 MBq, protein dose 5 mg 89Zr-bevacizumab. At day 1, day 15 and day 99, PET images will be made for visualization and quantification of VEGF in the tumor lesions and blood will be drawn for determination of angiogenesis and mTOR pathway related biomarkers.

Key Dates

First listed
Apr 19, 2011
Start date
Apr 30, 2010
Status verified
Aug 2011
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

Enrollment
14 participants (actual)

Arms

  • Arm: 89Zr-bevacizumab

Primary Outcome Measure

change in 89Zr-bevacizumab uptake [ Time Frame: 12 weeks ]

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