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

March 9, 2015 updated by: Washington University School of Medicine

Effectiveness in Head and Neck Cancer Detection Using PET Insert Device

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.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with biopsy proven squamous cell carcinoma of the head and neck with suspected lymph node metastasis

Description

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 staging.
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Yuan-Chuan Tai, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Study Completion (ANTICIPATED)

December 1, 2011

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (ESTIMATE)

May 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WashU-Tai10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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