Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug

The aim of this pilot study is to examine the utility of a new molecular imaging tracer, [F-18]RGD-K5 to monitor treatment responses in patients scheduled to undergo treatment with Avastin® (Bevacizumab) plus standard chemotherapy. The changes of [F-18]RGD-K5 PET/CT image scans between before treatment and after both mid-treatment cycles of Avastin® (Bevacizumab) will be evaluated. The hypothesis for this study is that changes in the uptake of [F-18]RGD-K5 PET in tumors may reflect changes in the level of integrin expression and/or angiogenesis. This pilot study will help to define if changes in uptake of [F-18]RGD-K5 are an early indicator of treatment efficacy to Avastin®.

Inclusion criteria

• Patient is >18 years and male or female of any race / ethnicity
• Patient or patient's legally acceptable representative provides written informed consent and willing to comply with protocol requirements
• Patient must be scheduled to receive chemotherapy treatment(s) plus Avastin® for their cancer care; treatment management will be made by the treating medical oncologists (According to the package insert for Avastin®, it is administered as an IV infusion every 3 weeks for nonsquamous non-small cell lung cancer, and every 2 weeks for metastatic breast cancer, colon or rectum cancer)
• Patient will be scheduled to have a clinical [F-18]FDG-PET/CT or diagnostic CT pre-treatment after the fourth but before the fifth Avastin® treatment

Exclusion criteria

• Patient is not capable of complying with study procedures
• Female patient is pregnant or nursing; exclude the possibility of pregnancy by one of the following:

• Confirming in medical history that the patient is postmenopausal for a minimum of one year, or surgically sterile
• Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera, or Norplant
• Confirming a negative urine dipstick test taken the morning of receiving the [F-18]RGD-K5
• Patient has a severe hepatic or renal disease as defined by previous medical history or abnormal renal and hepatic functions determined by lab results not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included:

• AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limits of normal
• Serum creatinine ≤ 2x institutional upper limits of normal
• BUN within 2x institutional upper limits of normal
• Patient has known hyper or hypo-coagulation syndromes. (e.g. Protein C, S deficiency, Hemophilia A/B/C, Factor-V Leiden, etc) or lab results are not within the following ranges, or in the opinion of the Investigator, the values are not acceptable for the patient to be included: Platelet counts of < 75 x 103/μL
• Patient has known sensitivity to any components of Avastin® such as recombinant human or humanized antibodies
• Patient has been involved in an investigative, radioactive research procedure within 7 days and during the study participation period
• Patient will participate in experimental therapy procedures while participating in this clinical trial
• Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data or data quality to achieve study objectives, or complete study and/or post-dose follow-up examinations