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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-09-11

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Head and Neck Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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PET/MRI

Patient receives PET/MRI

PET/MRI

Intervention Type DEVICE

Simultaneous PET/MRI (3T system)

Interventions

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PET/MRI

Simultaneous PET/MRI (3T system)

Intervention Type DEVICE

Other Intervention Names

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Siemens Biograph mMR

Eligibility Criteria

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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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No