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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Radiation: [F-18] HX4

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
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlations between T/B ratios of [F-18]HX4 uptake from pre-surgery PET imaging and immunohistochemistry measurements	Correlations between T/B ratios of [F-18]HX4 uptake from pre-surgery PET imaging and immunohistochemistry measurements obtained from surgical tumor samples	Estimated analysis to occur 1 month after patient surgery
Kinetic Modeling Analysis	Kinetic parameters obtained from modeling time course of PET imaging data following [F-18]HX4 administration	Estimated to be 2 weeks after the Imaging Date (Visit 2)
Safety Assessments	Safety measurements including incidence of adverse events, and pre- and post-drug clinical laboratory measurements, vital signs and electrocardiograms	On average of 3 weeks (from Time of Signing Consent to 24 hours after the Imaging Date)

Collaborators and Investigators

• Sponsor: Siemens Molecular Imaging
• Investigators: Principal Investigator: John Buatti, MD, University of Iowa Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: December 28, 2011
• First Submitted That Met QC Criteria: January 9, 2012
• First Posted (Estimate): January 10, 2012

Study Record Updates

• Last Update Posted (Estimate): December 17, 2012
• Last Update Submitted That Met QC Criteria: December 12, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; PET Imaging; Newly Diagnosed
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: HX4-201