An Efficacy and Safety Study to Assess [18F]-ML-10 in Detecting Response of Tumors to Chemotherapy and Radiation
Recruitment status was: Recruiting
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]).
|Carcinoma, Non-Small-Cell Lung Head and Neck Neoplasms||Other: [18F]-ML-10 in conjunction with PET imaging||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|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|
- To characterize changes in [18F]-ML-10 uptake in the target lesion in response to chemoradiotherapy. [ Time Frame: Between baseline and day 11 ± 1, and between baseline and day 18 ± 1 ]
- To assess the correlation between the changes in the uptake of [18F]-ML-10 in the target lesion and the changes in the anatomical dimensions of the target lesion.To assess the correlation between the changes in the uptake of [18F]-ML-10 in the target lesion following an accumulative radiation dose of 14.4-20.0 Gy, and the changes in the anatomical dimensions of the target lesion, as assessed by the follow-up anatomical imaging by CT, performed after completion of the concurrent chemoradiotherapy (CRT).
- To identify at least one parameter, derived from the changes in [18F]-ML-10 uptake that can discriminate tumors responsive to treatment from tumors that are non-responsive.For this parameter, various cut-off values of change will be evaluated, with corresponding estimates of sensitivity and specificity.
- To perform additional analyses for all other lesions and lymph nodes with at least one diameter ≥ 2 cm treated by concurrent CRT.
- To assess the safety of [18F]-ML-10 administered to cancer patients receiving concurrent CRT.
|Study Start Date:||December 2010|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Other: [18F]-ML-10 in conjunction with PET imaging
Subjects will receive two to three intravenous (IV) doses of [18F]-ML-10. The dose for each [18F]-ML-10 dose will be 5.50 MBq/Kg or 0.15 mCi/Kg but will not exceed 500.00 MBq (13.50 mCi) per administration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260480
|United States, Massachusetts|
|Boston, Massachusetts, United States|
|Contact: David Sher, MD DSHER@PARTNERS.ORG|
|United States, New Jersey|
|Holy Name Medical Center||Recruiting|
|Teaneck, New Jersey, United States, 07666|
|Contact: Benjamin Rosenbluth, MD firstname.lastname@example.org|
|United States, New York|
|New York, New York, United States, 10029|
|Contact: Lale Kostakoglu, MD, MPH email@example.com|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh,, Pennsylvania, United States, 15232|
|Contact: Heron Dwight, MD 412-623-1275|
|Principal Investigator:||Heron Dwight, MD||University of Pittsburgh|
|Principal Investigator:||David Sher, MD, MPH||BWH, Harvard|
|Study Director:||Aaron Allen, MD||Rabin Medical Center|