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

Completed

• Conditions: Head and Neck Cancer
• Interventions: Device: PET/MRI

• Registration Number: NCT02180308
• Lead Sponsor: NYU Langone Health

Brief 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-02
• Primary Completion: 2017-09-11
• Study Completion: 2018-09-11
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-12
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PET/MRI	PET/MRI	Patient receives PET/MRI

Primary Outcome Measures

Name	Time	Method
Accuracy of simultaneous FDG-PET/MRI for detection of nodal metastases	2 years after beginning of study (July 2014 - June 2016)	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.

Trial Locations

Locations (1)

NYU Langone Medical Center; 🇺🇸 New York, New York, United States