XCancer

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

Description:

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)

Government Study Link:

NCT01506427 - Click here to see study on

ClinicalTrials.gov

HX4

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

FDG

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