A Study of [F-18]HX4 (PET Imaging)Evaluated in Head and Neck Cancer Patients
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: Head and Neck Cancer
In brief
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.
Key facts
- Study ID
- NCT01506427
- Run by
- Siemens Molecular Imaging
- People needed
- 0
- Starts
- 2012-09-01
- Expected to finish
- 2013-06-01
- Last updated by the study team
- 2012-12-17
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Iowa Medical Center — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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