Lymph Node Assessment Using Simultaneous 18F-FDG-PET and MRI
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Head cancer, Neck cancer, MRI, PET
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: PET/MRI
Type: Device
Overall Status
Recruiting
Summary
The overarching goal of this study is to develop PET/MR techniques to accurately detect nodal metastases for surgical planning and assessment of treatment response.
Detailed Description
Patients (n = 30) with head and neck cancer who are scheduled for node dissection surgery are eligible. Enrolled subjects will undergo one research PET/MR scan at the Center for Biomedical Imaging (660 First Avenue) within one week prior to the planned surgery. During the dissection, the locations of removed lymph nodes will be noted in terms of conventional neck lymph node levels. PET/MR data will be used for development of a combined kinetic model analysis of PET and MRI data (Aim 1). The final PET/MR findings will be compared with pathological evaluation results in order to assess the accuracy of PET/MR for detection of nodal metastases (Aim 2).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

Patients with head and neck cancer who are scheduled for node dissection surgeries at NYU Langone Medical Center or Bellevue hospital are eligible.

Exclusion Criteria:

Normal MRI exclusion criteria will apply, including those on the following list. A standard MRI safety form will be used to identify potential conditions warranting exclusion.

- Electrical implants such as cardiac pacemakers or perfusion pumps

- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants

- Ferromagnetic objects such as jewelry or metal clips in clothing

- Claustrophobia

- History of seizures

- Diabetes In addition, patients with GFR < 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
Location
NYU Langone Medical Center
New York, New York, United States
Status: Recruiting
Contact: Simone Rainey - 212-263-2710 - simone.rainey@nyumc.org
Start Date
June 2014
Sponsors
New York University School of Medicine
Source
New York University School of Medicine
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page