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To date, there are no methods to reliably select which patients with non-squamous non-small cell lung cancer (NSCLC) that benefit most from treatment with bevacizumab. Data have shown that high levels of plasma VEGF are prognostic and correlates with a worse disease outcome in some tumour types, including advanced NSCLC.
Recent data are suggestive of a predictive value of imaging techniques for early detection of antiangiogenic treatment efficacy in different cancers. To our knowledge there are no presented data available on correlation between changes in diffusion-weighted MR and response to bevacizumab treatment in lung cancer. The current study is designed as a pilot study to prospectively investigate changes in MR variables during treatment with bevacizumab and to detect signals of prognostic and/or predictive value of MR changes during treatment.
Full description
A Non Interventional, open-label, single arm, single institution pilot study. Eligible patients will be monitored by diffusion-weighted magnetic resonance tomography (dMRT) during treatment with bevacizumab + chemotherapy for up to four cycles followed by bevacizumab maintenance therapy until disease progression.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Written informed consent obtained prior to any study-specific procedure
Age ≥18 years
Able to comply with the protocol
Histologically or cytologically documented inoperable, metastatic (Stage IV) non small cell lung cancer
ECOG PS status 0-1
Life expectancy ≥12 weeks
Adequate haematological function:
Adequate liver function:
Adequate renal function:
Normal values of INR within 7 days prior to enrolment
If female, should not be pregnant or breast-feeding. Women with an intact uterus (unless amenorrhoeic for the last 24 months) must have a negative serum pregnancy test within 28 days prior to enrolment into the study.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
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Central trial contact
Karl-Gustav Kölbeck, MD; Eeva Alamartimo, RN
Data sourced from clinicaltrials.gov
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