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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Siemens Molecular Imaging
ClinicalTrials.gov Identifier:
NCT01506427
First received: December 28, 2011
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Head and Neck Cancer
Radiation: [F-18] HX4
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Siemens Molecular Imaging:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    Correlations between T/B ratios of [F-18]HX4 uptake from pre-surgery PET imaging and immunohistochemistry measurements obtained from surgical tumor samples

  • Kinetic Modeling Analysis [ Time Frame: Estimated to be 2 weeks after the Imaging Date (Visit 2) ] [ Designated as safety issue: No ]
    Kinetic parameters obtained from modeling time course of PET imaging data following [F-18]HX4 administration

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


Enrollment: 0
Study Start Date: September 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [F-18] HX4 Radiation: [F-18] HX4
A single dose of 10 mCi, injected intravenously.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506427

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

No publications provided

Responsible Party: Siemens Molecular Imaging
ClinicalTrials.gov Identifier: NCT01506427     History of Changes
Other Study ID Numbers: HX4-201
Study First Received: December 28, 2011
Last Updated: December 12, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 20, 2014