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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180308
• Other study ID #: 14-00434
• Status: Completed
• Start date: June 2014
• Est. completion date: September 11, 2018

Study information

• Verified date: April 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 11, 2018
• Est. primary completion date: September 11, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Device:
• PET/MRI
Simultaneous PET/MRI (3T system)

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)