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A Phase I/II, Open Label, Nonrandomized, Multi-Center Study of [F-18]HX4 Positron Emission Tomography (PET) in Head and Neck Cancer Patients

Phase 1/Phase 2
Not Enrolling
Head and Neck Cancer

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Trial Information

A Phase I/II, Open Label, Nonrandomized, Multi-Center Study of [F-18]HX4 Positron Emission Tomography (PET) in Head and Neck Cancer Patients

Each consented patient will have a single administration of [F-18]HX4 and will immediately
undergo one list mode PET/CT imaging session lasting 60 minutes followed by three additional
list mode PET/CT acquisitions from 90 to 110 minutes, 150 to 170 minutes and 220 to 250
minutes after administration. The start times of the last three image acquisitions are
permitted to be within ± 5 minutes. Venous blood samples will be collected throughout the
initial scan sequence and at the time of each subsequent acquisition for calibration and
metabolite-correction of the image-derived input function. On the day of administration
(Visit 2) blood for clinical safety evaluations will be drawn pre- and post-dosing after all
imaging is complete.

The pre-surgery [F-18]FDG PET/CT clinical scan performed prior to the [F-18]HX4 procedure,
and the surgery at Visit 3 are standard of care for the consented patients.

Inclusion Criteria:

- 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.

- 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

- Patient is scheduled to undergo complete tumor resection within 7 days for his/her
cancer care after the [F-18]HX4 PET/CT scan is performed.

- Patient has not had nor will have neoadjuvant treatment, including radiation and
chemotherapy, prior to patient's planned tumor resection.

Exclusion Criteria:

- Female patient is pregnant or nursing.

- Patient is not capable of remaining still for duration of imaging procedure (~ 4

- 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 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Serial measures of T/B Ratios and other imaging parameters

Outcome Description:

Serial measures of T/B ratios and other imaging parameters derived from the course imaging data of head and neck cancer pateitns in order to determine time of optimal imaging.

Outcome Time Frame:

Approximately 1 month after patient imaging; comprehensive analysis will be concluded within 1 month after Last Patient Out

Safety Issue:


Principal Investigator

John Buatti, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

June 2013

Related Keywords:

  • Head and Neck Cancer
  • Newly Diagnosed
  • Head and Neck Cancer
  • PET Imaging
  • Head and Neck Neoplasms



University of Iowa Medical Center Iowa City, Iowa  52242