Detection of Cervical Lymph Node Metastases With a High-Resolution Positron Emission Tomography (PET) Imaging System

NCT01030497 | Completed

• 1 other identifier: 2009-0477
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if using the PEMFlex Solo II, a high-resolution camera for PET scan imaging, on an area of the body that has, or is suspected to have cancer will give researchers the same or better information about the disease compared to the images taken with a routine PET/CT. Researchers will compare the images taken using the PEMFlex Solo II to the images taken during your scheduled routine PET/CT scan, as well as any additional routine CT scan(s), magnetic resonance imaging (MRI) scan(s), and/or ultrasound image(s) you may have had within the last 30 days or may have in the next 30 days.

Conditions

Head and Neck Cancer

Keywords

Cancer; Cervical Lymph Node Metastases; High-Resolution PET Imaging System; Upper Aerodigestive Tract; Head; Neck; HR PET Imaging System; High-Resolution PET; PET/CT; PEMFlex Solo II; positron emission tomography/computed tomography (PET/CT)

Outcome Measures

Primary Outcomes (1)

• Number of peripheral tumor lesions identified in standard PET/CT imaging also identifiable in PEM images.

  20 minutes for imaging using PEMFlex Solo II, within ± 30 days of standard PET/CT imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with known or suspected primary cancer of the upper aerodigestive tract or metastatic disease to cervical lymph nodes, over 18 years of age, and scheduled for routine clinical imaging at the PET/CT facility.

You may qualify if:

• A signed informed consent.
• Known or suspected primary cancer of the upper aerodigestive tract, which may be determined by biopsy, physical examination- including upper endoscopy or noninvasive imaging studies including CT, MR, ultrasound, or prior PET.
• Known or suspected metastatic disease to cervical lymph nodes based on physical examination, imaging studies or biopsy.
• Scheduled for routine clinical imaging at the ACB PET/CT facility.
• Participant must be at least 18 years of age.

You may not qualify if:

• Prior treatment (chemotherapy, radiotherapy) for cancer of the upper aerodigestive tract.
• Prior biopsy procedures, including resection of the primary cancer, will not exclude the patient from participation.
• Uncontrolled blood glucose levels (\>200 mg/dl).
• Patient is unable to comprehend the requirements of the study.
• Patient is unable to undergo scanning of the neck with the PEM (PET) scanner (due to body habitus, inability to comply with positioning requirements, etc.).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site

Study Officials

• Eric Rohren, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 11, 2009
• Study Start: December 1, 2009
• Primary Completion: May 1, 2014
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

US (1)