TheranosticTrials.org

Clinical Trial · NCT01506427

A Study of [F-18]HX4 (PET Imaging)Evaluated in Head and Neck Cancer Patients

Overview

The purpose of this trial is to determine what will be the optimal imaging protocol for Head and Neck Cancer patients after \[F-18\] HX4 injection. This study will provide guidance for future studies involving \[F-18\]HX4 in cancer patients.

Sponsor

Unknown Organization

Phase

Phase 1/2

Contacts

Edward Aten, MD (STUDY_DIRECTOR)

John Buatti, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01506427

Drug / Compound

HX4

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

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Patient has newly diagnosed histologically confirmed squamous cell carcinoma of the head and/or neck whose primary origin is from the oral cavity, oropharynx, hypopharynx, larynx or nasopharynx.
  • Patient is scheduled to have or already has had a clinical \[F-18\]FDG PET/CT scan prior (recommended to be within 14 days prior) to the \[F-18\]HX4 PET/CT scan.
  • Patient has a primary tumor ≥ 2.0 cm in longest axis measured by CT or MR; or lymph node ≥ 2.0 cm in shortest axis measured by CT or MR if primary tumor \< 2 cm on CT or MR; CT may be part of required \[F-18\]FDG PET/CT scan or a separate pre-surgery CT scan.
  • * Patient is \>18 years and male or female of any race / ethnicity.
  • Patient or patient's legally acceptable representative provides written inform consent Patient is willing and able to comply with protocol procedures.

Exclusion

  • Patient has chronic renal function failure or is on renal dialysis
  • Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data.
  • * Female patient is pregnant or nursing.
  • Patient has undergone an investigative, radioactive research procedure within 7 days prior to study participation, or is scheduled to undergo such a procedure during the study participation period.
  • Patient is not capable of remaining still for duration of imaging procedure (\~ 4 hours).