Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
by two modalities: FLT-PET and MRI. MRI is considered standard of care and response assessments are recorded as CR, PR, PD, SD, and unknown (see section 12.0). FLT-PET response assessments will be recorded as SUV-MAX and a decline by 25% is considered as significant (see Section 12.0). MRI measurements will be recorded at baseline and 10 to 12 weeks post WBRT. FLT-PET measurements will be recorded at baseline, 10 days post WBXRT, and 10-12 weeks post WBXRT.
Andrew Seidman, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|