A phase II, open label, non-randomized, multi-center, pilot, efficacy study of [F-18]RGD-K5 positron emission tomography (PET) as a tool to monitor response to an anti-angiogenic drug

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

• Patient is >18 years and male or female of any race / ethnicity
• Patient 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 treating medical oncologists (According to the package insert for Avastin®, it is administered as an IV infusion every 3 weeks for non-squamous 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 pretreatment, and 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
• 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:
o AST (SGOT)/ALT (SGPT) <= 2.5 x institutional upper limits of normal
o Serum creatinine <= 2x institutional upper limits of normal
o 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:
o 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 or 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective for this study is:<br /><br>• To explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early<br /><br>response to<br /><br>Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the<br /><br>full course<br /><br>of treatment is completed</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective for this study is:<br /><br>• To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study<br /><br>design<br /><br>and conduct of future studies</p><br>

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