Lymph Node Assessment Using Simultaneous 18F-FDG-PET and MRI

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Device: PET/MRI

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).

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center

Participation Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PET/MRI; Patient receives PET/MRI	Device: PET/MRI; Simultaneous PET/MRI (3T system); Other Names: Siemens Biograph mMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of simultaneous FDG-PET/MRI for detection of nodal metastases	This study is to assess PET/MR techniques for detection of nodal metastases for surgical planning and assessment of treatment response. Our central hypothesis is glucose metabolic rate (GMR) measured using a simultaneous PET/MR scanner can more accurately detect nodal metastases than standardized uptake value (SUV) measures from PET alone. SUV depends on both tumor metabolic rate and tracer delivery, which makes the interpretation of SUV challenging. For instance, an inflammatory node can have high SUV due to increased vascularity and vascular permeability and cannot be easily differentiated from a metastatic node, based on SUV. However, we hypothesize that inflammatory nodes will have lower GMR than metastatic nodes that contain highly proliferating cancer cells, such that they can be differentiated from metastatic nodes more reliably. This study will also determine if simultaneously acquired MRI can reduce uncertainty in GMR measurement of PET.	2 years after beginning of study (July 2014 - June 2016)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Sungheon Kim, PhD, NYU School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): September 11, 2017
• Study Completion (Actual): September 11, 2018

Study Registration Dates

• First Submitted: July 1, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimate): July 2, 2014

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: MRI; PET; Head cancer; Neck cancer
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 14-00434

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No