Status:
COMPLETED
18F ML-10 for Early Detection of Response of Brain Metastases to WBRT
Lead Sponsor:
Aposense Ltd.
Conditions:
Solid Tumors
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the potential of \[18F\]-ML-10 to serve as a non-invasive imaging tool for the early detection of apoptosis in brain metastases in response to radiation therap...
Detailed Description
Early assessment of the efficacy of anti-cancer therapy is highly desirable and an unmet need in clinical oncology. Currently, treatment efficacy is mostly measured by following tumor size by anatomic...
Eligibility Criteria
Inclusion
- Patients with cancer, diagnosed as having brain metastases, wherein at least one of the tumors has the diameter of ≥ 1.5cm, as assessed by MRI or CT performed within 14 days prior to screening/enrollment.
- Patients scheduled for WBRT.
- Fully conscious patients who have been given written and verbal information, and have then provided informed consent.
Exclusion
- Unstable medical condition, such as ischemic heart disease, liver disease or pulmonary disease, which may risk the patient during the study, as judged by the investigator.
- Renal failure, with serum creatinine \> 1.5mg/dl.
- Any known psychiatric disorder other than mild depression or anxiety.
- Patients treated for diabetes mellitus either by oral hypoglycemic medications or insulin.
- Allergy to any known medication or to any imaging agent, or allergy-originated diseases, as judged by the investigator.
- Other condition that might jeopardize the safety of the patient or the evaluation of the study results, as judged by the investigator.
- Treatment with any non-marketed investigational drug within 30 days prior to administration of \[18F\]-ML-10.
- Current alcohol or drug abuse
- Pregnancy or lactation.
- Women of child-bearing potential who are not using an adequate and medically acceptable contraceptive method.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00791063
Start Date
March 1 2008
End Date
December 1 2008
Last Update
February 13 2013
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