Effectiveness in Head and Neck Cancer Detection Using Positron Emission Tomography (PET) Insert Device

Withdrawn before enrolling

Conditions studied: Squamous Cell Carcinoma of the Head and Neck

In brief

We have developed a prototype PET insert device that can be integrated into a clinical PET/computed tomography (CT) scanner to improve its image resolution to approximately 2.5 mm in all 3 dimensions within a reduced imaging field of view (FOV). This zoom-in imaging capability provides 6-fold improvement in volumetric image resolution over the current state-of-the-art clinical PET scanner, offering a tremendous opportunity for cancer imaging applications, in particular for those cases where a lymph node involvement will drastically alter the patient management plan. Accurate diagnosis and staging of head-and-neck cancer is known to be challenging because of the complex anatomy and large number of lymph nodes involved in this region. As a result, head and neck cancer imaging is an ideal candidate for evaluating the clinical usefulness of this novel imaging device.

Key facts

Study ID: NCT01133262
Run by: Washington University School of Medicine
People needed: 0
Starts: 2010-06-01
Expected to finish: 2011-12-01
Last updated by the study team: 2015-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically confirmed squamous cell carcinoma of the head and neck with suspected lymph node metastasis. Subjects with histological confirmation of squamous cell carcinoma from a lymph node biopsy in the head and neck region for carcinoma of unknown primary would also be eligible.
Patient must be scheduled to receive (or have already received) clinical whole body PET/CT scan from a Siemens Biograph 40 PET/CT scanner as their standard of care staging.
Patient must be scheduled to receive surgical removal of the primary tumor and the regional lymph nodes. It is preferred that the surgery will occur within 21 days of research PET imaging.
Age >18 years, as head and neck cancer is extremely rare in children.
Ability of the patient (or legally authorized representative if applicable) to understand and the willingness to sign a written informed consent document.
Not currently pregnant or nursing: Female subjects must be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), or post menopausal (cessation of menses for more than 1 year). If of childbearing potential, a urine pregnancy test must be performed within the 24 hour period immediately prior to administration of 18FDG and determined to be negative

You may not qualify if…

The subject weight will be limited to 250 lbs and below due to the size limitations of the prototype PET insert device.
Subjects who are claustrophobic
Subjects with poorly controlled diabetes (fasting blood glucose >200mg/dL)
Subjects with prior head/neck surgery or radiation as this may disturb the natural architecture of the tissues and impede the imaging analysis

Where it is running

Barnes-Jewish Hospital — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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