TheranosticTrials.org

Clinical Trial · NCT01260480

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

Overview

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 \[MRI\]).

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Heron Dwight, MD (PRINCIPAL_INVESTIGATOR)

David Sher, MD, MPH (PRINCIPAL_INVESTIGATOR)

Aaron Allen, MD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT01260480

Drug / Compound

ML-10

Isotope(s):
Target(s):
  • Apoptosis
Ligand Class: Small Molecules

ML-10

Isotope(s):
Target(s):
  • Caspase-3
Ligand Class: Small Molecules

Eligibility

Inclusion

  • A measurable primary tumor with at least one diameter \> 2 cm or primary tumor extending to one or more lymph nodes which cannot be distinctively delineated as confirmed by a diagnostic quality chest CT performed within 4 weeks prior to initiation of the concurrent CRT.
  • Previously untreated, histologically or cytologically confirmed stage IIB, IIIA or IIIB disease, without evidence of distant metastases
  • Planned to receive concurrent chemoradiotherapy as definitive treatment. The radiation dose should not exceed 70 Gy.
  • Undergone the following minimum workup to confirm disease staging within 4 weeks prior to initiation of the concurrent CRT:
  • Male or female patients with either:Newly diagnosed non small cell lung cancer (NSCLC) (Group A) who meet the following criteria:

Exclusion

  • Predominant small cell carcinoma histology.
  • Malignant pleural or pericardial effusions.
  • Exclusion criteria specific to patients with NSCLC (Group A):
  • Treatment planned with chemotherapy other than a platinum-based doublet regimen.
  • Pure bronchioalveolar cell carcinoma histology.