Status:
WITHDRAWN
A Study of [F-18]HX4 (PET Imaging)Evaluated in Head and Neck Cancer Patients
Lead Sponsor:
Siemens Molecular Imaging
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
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 ...
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/...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01506427
Start Date
September 1 2012
End Date
June 1 2013
Last Update
December 17 2012
Active Locations (1)
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1
University of Iowa Medical Center
Iowa City, Iowa, United States, 52242