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Effectiveness in Head and Neck Cancer Detection Using PET Insert Device

18 Years
Not Enrolling
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

Effectiveness in Head and Neck Cancer Detection Using PET Insert Device

In this project, we propose to conduct an exploratory clinical trial to investigate the
effectiveness of this novel imaging device in detecting small lesions and lymph node
involvements in the head and neck region, and compare its results to those obtained from a
clinical PET/CT scanner. More specifically, we propose to (1) recruit 5 patients who have
confirmed head and neck cancer and are scheduled to receive a whole-body PET/CT scan
followed by surgical operation to remove the primary tumor and the regional lymph nodes.
These patients will be imaged by a state-of-the-art PET/CT scanner using the standard
whole-body PET/CT imaging protocol as standard of care for initial staging. On another day,
following consent to participate in this research protocol, A patient will undergo images of
the head and neck region using the same type scanner with and without our novel PET insert
device attached; (2) The images obtained from the PET insert device will be reviewed by
experienced nuclear medicine physicians to identify the extent of lymph node involvement.
The PET insert images will be compared to the standard clinical PET/CT images. A detailed
image obtained for purposes of research, centered at the level of the head and neck,
acquired for approximately 3 times the length of time the standard clinical image is
obtained for will also be compared to the PET insert image. Images will also be compared to
the pathology report of the surgically removed specimen. (3) Estimate the performance of
lesion detection for different sizes of tumors using the standard PET/CT scanner as well as
the PET insert device.

Inclusion Criteria:

1. 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.

2. 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

3. 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.

4. Age >18 years, as head and neck cancer is extremely rare in children.

5. Ability of the patient (or legally authorized representative if applicable) to
understand and the willingness to sign a written informed consent document.

6. 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

Exclusion Criteria:

1. The subject weight will be limited to 250 lbs and below due to the size limitations
of the prototype PET insert device.

2. Subjects who are claustrophobic

3. Subjects with poorly controlled diabetes (fasting blood glucose >200mg/dL)

4. Subjects with prior head/neck surgery or radiation as this may disturb the natural
architecture of the tissues and impede the imaging analysis

Type of Study:


Study Design:

Time Perspective: Prospective

Principal Investigator

Yuan-Chuan Tai, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

June 2010

Completion Date:

December 2011

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



Barnes-Jewish Hospital Saint Louis, Missouri  63110