Status:
TERMINATED
18F ML-10 for Early Detection of Response of Brain Metastases to SRS
Lead Sponsor:
Aposense Ltd.
Conditions:
Metastasis to Brain of Unknown Primary
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
- The Patient may only be included in the study if ALL of the following statements are fulfilled:
- Male or female patient diagnosed with metastatic non hematological cancer, with up to 4 brain metastases of which at least one has a minimal diameter of 1.5cm , as assessed by MRI (utilized for SRS planning) and is scheduled for SRS. These metastases will be defined as target lesions.
- Patient is ≥ 18 years of age at the time of signature of the informed consent form.
- Fully conscious patient who has been given written and verbal information, and has then provided an informed consent.
- Patient who is able to cooperate with the studies requirements to lie still during PET/CT imaging scans, which may last for up to 3 hours.
- ECOG performance status of 0, 1 or 2 at the time of enrollment.
- Patient with life expectancy ≥ 12 weeks.
- Adequate renal function and adequate hepatic function as assessed by standard laboratory criteria and defined as:
- Creatinine clearance ≥ 60 ml/min/1.73m2according to Cockroft \& Gault Formula
- Total bilirubin ≤ 1.5 times the ULN
- Aspargine aminotransferase (AST), alanine aminotransferase (ALT) ≤ 3 times the ULN in patients without liver metastases; ≤ 5 times the ULN in patients with liver metastases
- Serum calcium levels, adjusted to albumin level, within normal limits.
- For a female patient, pregnancy or breast-feeding are restricted. Woman of child bearing potential must have a negative serum pregnancy test at screening.
Exclusion
- If any apply, the patient must not be included in the study:
- Unstable medical condition, such as severe ischemic heart disease, liver disease or pulmonary disease, which may risk the patient during the study, as judged by the investigator.
- Any indication of imminent brain herniation
- Any known psychiatric disorder other than mild depression or anxiety.
- Known allergy to Gadolinium
- 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
- Patient who received Whole Brain Radiation Therapy (WBRT) within 6 months prior screening and/or planned to receive WBRT 8 weeks post SRS
- Patient receiving concurrent treatment with temozolamide or planned to receive temozolamide within 8 weeks post SRS
- Woman of child-bearing potential who is not using an adequate and medically acceptable contraceptive method. Men who do not agree to use effective contraception during the study and for a period of 60 days following the last administration of \[18F\]-ML-10.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00696943
Start Date
July 1 2008
End Date
July 1 2009
Last Update
February 15 2013
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