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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01506427
Recruitment Status : Withdrawn
First Posted : January 10, 2012
Last Update Posted : December 17, 2012
Information provided by (Responsible Party):
Siemens Molecular Imaging

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiation: [F-18] HX4 Phase 1 Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I/II, Open Label, Nonrandomized, Multi-Center Study of [F-18]HX4 Positron Emission Tomography (PET) in Head and Neck Cancer Patients
Study Start Date : September 2012
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: [F-18] HX4 Radiation: [F-18] HX4
A single dose of 10 mCi, injected intravenously.

Primary Outcome Measures :
  1. Serial measures of T/B Ratios and other imaging parameters [ Time Frame: Approximately 1 month after patient imaging; comprehensive analysis will be concluded within 1 month after Last Patient Out ]
    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.

Secondary Outcome Measures :
  1. Correlations between T/B ratios of [F-18]HX4 uptake from pre-surgery PET imaging and immunohistochemistry measurements [ Time Frame: Estimated analysis to occur 1 month after patient surgery ]
    Correlations between T/B ratios of [F-18]HX4 uptake from pre-surgery PET imaging and immunohistochemistry measurements obtained from surgical tumor samples

  2. Kinetic Modeling Analysis [ Time Frame: Estimated to be 2 weeks after the Imaging Date (Visit 2) ]
    Kinetic parameters obtained from modeling time course of PET imaging data following [F-18]HX4 administration

  3. Safety Assessments [ Time Frame: On average of 3 weeks (from Time of Signing Consent to 24 hours after the Imaging Date) ]
    Safety measurements including incidence of adverse events, and pre- and post-drug clinical laboratory measurements, vital signs and electrocardiograms

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 scan.
  • 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 hours).
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01506427

United States, Iowa
University of Iowa Medical Center
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Siemens Molecular Imaging
Principal Investigator: John Buatti, MD University of Iowa Medical Center
Study Director: Edward Aten, MD President, Certus International

Responsible Party: Siemens Molecular Imaging Identifier: NCT01506427     History of Changes
Other Study ID Numbers: HX4-201
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by Siemens Molecular Imaging:
Newly Diagnosed
Head and Neck Cancer
PET Imaging

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site