An Open-label, Multi-center Study to Evaluate [18F]-ML-10 as a PET Imaging Radiotracer for Early Detection of Response of Brain Metastases to Stereotactic Radio Surgery (SRS)
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 anatomical imaging (CT scan or MRI). However, changes in tumor size may be
observed only after several weeks to several months after completion of treatment.
Meanwhile, in cases where there is no response, the patient is unnecessarily exposed to
treatment's side effects, and precious time may be lost before the initiation of an
alternative, potentially more beneficial line of therapy. Therefore, there is an urgent and
serious need for better tools for monitoring of tumor response to anti-cancer treatments.
To address this need, [18F]-ML-10, a novel small molecular-weight probe (MW 205) was
developed for clinical detection of apoptosis in vivo by positron emission tomography (PET).
[18F]-ML-10 is a member of the ApoSense family of compounds, a novel class of molecular
probes for molecular imaging of cell death. The first clinical indication for which
[18F]-ML-10 is being developed is imaging of apoptosis in clinical oncology to monitor tumor
response to radiation therapy.
Previous preclinical and clinical studies have substantiated the safety of [18F]-ML-10, its
very high stability in vivo, its favorable biodistribution profile, and its efficacy in
clinical detection of cell death. In preclinical studies, the selective retention of
[18F]-ML-10 in the focus of the neurovascular cell death in cerebral ischemia was
demonstrated in respective animal models. [18F]-ML-10 has been examined in two clinical
trials in Uppsala Imanet, Sweden, and has been found safe in administration to healthy
subjects and to elderly subjects with acute ischemic cerebral stroke. In these clinical
trials, [18F]-ML-10 was also found efficacious in the clinical imaging of apoptosis, being
either physiological apoptosis as observed in the testes in young healthy males, and
pathological cell death, as observed in the brains of patients with acute ischemic cerebral
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Assessment of the change in the uptake of [18F]-ML-10 by the target lesion(s) in response to SRS, as observed by comparing the PET/CT scans before and after SRS. Target lesion is defined as having a minimal diameter of 1.5 cm
Israel: Israeli Health Ministry Pharmaceutical Administration