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An Open-Label Study to Evaluate 18F ML-10 as a PET Imaging Radiotracer for Early Detection of Response of Brain Metastases to Whole Brain Radiation Therapy (WBRT)

Phase 2
18 Years
Not Enrolling
Solid Tumors, Brain Metastases

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Trial Information

An Open-Label Study to Evaluate 18F ML-10 as a PET Imaging Radiotracer for Early Detection of Response of Brain Metastases to Whole Brain Radiation Therapy (WBRT)

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 stroke.

Inclusion Criteria:

1. 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.

2. Patients scheduled for WBRT.

3. Fully conscious patients who have been given written and verbal information, and have
then provided informed consent.

Exclusion Criteria:

1. 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

2. Renal failure, with serum creatinine > 1.5mg/dl.

3. Any known psychiatric disorder other than mild depression or anxiety.

4. Patients treated for diabetes mellitus either by oral hypoglycemic medications or

5. Allergy to any known medication or to any imaging agent, or allergy-originated
diseases, as judged by the investigator.

6. Other condition that might jeopardize the safety of the patient or the evaluation of
the study results, as judged by the investigator.

7. Treatment with any non-marketed investigational drug within 30 days prior to
administration of [18F]-ML-10.

8. Current alcohol or drug abuse

9. Pregnancy or lactation.

10. Women of child-bearing potential who are not using an adequate and medically
acceptable contraceptive method.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Assessment of a change in the uptake of [18F]- ML-10 by the tumor as observed in comparing the PET scans before and after WBRT.

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Aaron Allen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rabin Medical Center, Petach Tikva 49100, Israel


Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

March 2008

Completion Date:

December 2008

Related Keywords:

  • Solid Tumors
  • Brain Metastases
  • cell death
  • Apoptosis
  • PET imaging
  • brain metastases
  • whole brain radiation therapy
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms