Status:
UNKNOWN
Evaluation of the Efficacy and Safety of [18F]-ML-10, as a PET Imaging Radiotracer, in Early Detection of Response of Brain Metastases of Solid Tumors to Radiation Therapy.
Lead Sponsor:
Aposense Ltd.
Conditions:
Brain Metastases
Solid Tumors
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 an imaging tool for the early detection of response of brain metastases to radiation therapy. Such early detection m...
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
- Male or female patients with metastatic non- hematological solid tumors, with one or more brain metastases, of which at least one lesion has a diameter ≥1.5 cm, as confirmed by anatomical imaging (GBCA-enhanced MRI), wherein this lesion (or lesions) is scheduled to be treated by SRS.
- ECOG performance status of 0, 1 or 2 at the time of enrollment.
- Women of child-bearing potential must have a negative blood pregnancy test at screening and use an adequate and medically acceptable contraceptive method.
- Willing and able to follow the protocol requirements.
- Able to provide written informed consent.
Exclusion
- Unstable medical condition, such as ischemic heart disease, or any other disease or medical condition that may place the patient at added risk during the study, as assessed by the Principal Investigator. A patient with a seizure disorder, focal or generalized, not adequately controlled by anti-convulsant therapy, and /or patient who have experienced an event of focal or generalized seizure within 7 days prior to screening will be considered neurologically unstable.
- Any indication of a risk for an imminent brain herniation, as evaluated by the Principal Investigator, based on the findings on brain MRI.
- Treatment with whole brain radiation therapy (WBRT) within 3 months prior to screening.
- Evidence for hemorrhage within any of the brain metastases.
- Any known psychiatric disorder other than mild depression or anxiety that may affect adherence to the study requirements.
- Known allergy to gadolinium.
- Any contraindication to MR imaging (e.g., metal implant, aneurysm clip, pacemaker).
- Other condition that, in the opinion of the Investigator, might jeopardize the safety of the patient, or the adequate evaluation of study results.
- Treatment with any investigational drug, device or biologic agent within 30 days prior to administration of \[18F\]-ML-10.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00805636
Start Date
November 1 2008
End Date
October 1 2010
Last Update
May 12 2010
Active Locations (4)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Department of Radiation oncology, Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
4
UPMC Shadyside Radiation Oncology
Pittsburgh, Pennsylvania, United States, 15232