MedTrace Logo

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

NCT01260480 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-12-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Aposense Ltd.

    lead INDUSTRY

Principal Investigators

  • Heron Dwight, MD · University of Pittsburgh Medical Center

  • David Sher, MD, MPH · BWH, Harvard

  • Aaron Allen, MD · Rabin Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01260480 on ClinicalTrials.gov