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Brief Title: An Efficacy and Safety Study to Assess [18F]-ML-10 in Detecting Response of Tumors to Chemotherapy and Radiation
Official Title: A Prospective, Multicenter Study, to Evaluate the Efficacy and Safety of [18F]-ML-10, a Positron Emission Tomography (PET) Imaging Radiotracer, in Early Detection of Response of Non-Hematological Tumors to Concurrent Chemoradiotherapy
Study ID: NCT01260480
Brief Summary: The purpose of this study is to determine whether \[18F\]-ML-10 used in conjunction with PET imaging is effective as an imaging tool for the early detection of response of oncological tumors in the lungs,head and neck to chemoradiation therapy. The study will evaluate the potential of \[18F\]-ML-10 used in conjunction with PET imaging to distinguish early during the course of chemoradiation therapy between a tumor that responds to the therapy, and a tumor that does not respond to the therapy. Currently, this distinction is available to the physician several weeks or months after completion of therapy, using anatomical imaging (for example Computed Tomography \[CT\] or Magnetic Resonance Imaging \[MRI\]).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
BWH, Boston, Massachusetts, United States
Holy Name Medical Center, Teaneck, New Jersey, United States
Mount Sinai, New York, New York, United States
University of Pittsburgh, Pittsburgh,, Pennsylvania, United States
Name: Heron Dwight, MD
Affiliation: University of Pittsburgh Medical Center
Role: PRINCIPAL_INVESTIGATOR
Name: David Sher, MD, MPH
Affiliation: BWH, Harvard
Role: PRINCIPAL_INVESTIGATOR
Name: Aaron Allen, MD
Affiliation: Rabin Medical Center
Role: STUDY_DIRECTOR