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

NCT02180308 | Completed DMC FDA Device

• 1 other identifier: 14-00434
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head cancer; Neck cancer; MRI; PET

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

PET/MRI

Patient receives PET/MRI

Device: PET/MRI

Interventions

PET/MRI DEVICE

Simultaneous PET/MRI (3T system)

Also known as: Siemens Biograph mMR

PET/MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Sungheon Kim, PhD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: June 1, 2014
• Primary Completion: September 11, 2017
• Study Completion: September 11, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

US (1)