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.
Conditions
Interventions
Product Name: [18F]-RGD-K5
Pharmaceutical Form: Intravenous infusion
Sponsors
Siemens Molecular Imaging
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective for this study is to explore the usefulness of [F-18]RGD-K5 PET/CT to predict efficacy or early response to Avastin® (the anti-angiogenesis drug) plus chemotherapy treatment before the full course of treatment is completed.;Secondary Objective: • To continue safety evaluation by collection of safety data from all patients • To gain experience with [F-18]RGD-K5 PET/CT in order to improve the study design and conduct of future studies ;Primary end point(s): • To use [F-18]RGD-K5 PET/CT imaging acquired at several times points to evaluate tumor response to Avastin® at earlier time points (changes from baseline to after the second but before the third Avastin® treatment, and from baseline to after the fourth but before the fifth Avastin® treatment) • To compare lesion changes in a paired image assessment from the diagnostic CT or [F-18]FDG PET/CT with the lesion changes in a paired image assessment from [F-18]RGD-K5 PET/CT obtained from pretreatment and after the fourth Avastin® treatment | — |
Countries
Belgium
Outcome results
None listed