NCT01260480

An Efficacy and Safety Study to Assess [18F]-ML-10 in Detecting Response of Tumors to Chemotherapy and Radiation

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Aposense Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 \[MRI\]).

Conditions

• Carcinoma, Non-Small-Cell Lung
• Head and Neck Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-02-01
• First posted: 2010-12-15
• Last updated: 2010-12-17

Locations

4 sites across 1 country: United States