Status:
COMPLETED
Efficacy Study of [F-18]RGD-K5 Positron Emission Tomography (PET) as a Tool to Monitor Response to an Anti-angiogenic Drug
Lead Sponsor:
Siemens Molecular Imaging
Conditions:
Metastatic Breast Cancer
Metastatic Colon/Rectum Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A Pilot Phase II Study 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) pl...
Detailed Description
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® (Bevaciz...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00988936
Start Date
September 1 2009
End Date
May 1 2012
Last Update
August 22 2012
Active Locations (8)
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1
University of California, Irvine
Irvine, California, United States, 92697-5020
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
UMDNJ
Newark, New Jersey, United States, 07103
4
Beth Israel Medical Center
New York, New York, United States, 10003