Skip to main content
OpenTrials
Completed

NCT Number: NCT04750434

PET MRI as a Staging Tool for Head and Neck Cancer

To explore the use of PET/MRI in the staging and pretreatment evaluation of patients with head and neck cancer and to compare this modality to standard PET/CT imaging.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

About this study

This study is a prospective clinical study whereby an emerging technology, PET/MRI will be compared to a more standard imaging modality, PET/CT, using newly diagnosed head and neck cancer patients as subjects. PET/MRI will also be used in this study to explore the merits of this new technology in determining extent of disease, functional impact, and potential treatment outcome.

In this study, subjects suitable for enrollment will be identified by the investigators involved in the study. These subjects will be identified through contact with these investigators and referred for enrollment per protocol. This protocol will include determining enrollment suitability based on inclusion and exclusion criteria. Once accepted as a candidate for the study, the newly diagnosed head and neck cancer patients will undergo both PET/CT and PET/MRI imaging within one week of each other. These studies will then be reviewed by a radiologist specializing in Head and Neck radiology familiar with PET imaging. The studies will be compared for any imaging differences. The imaging findings will then be correlated with pathological findings after surgery to determine if there are any consistent findings that correlate with adverse pathological findings, if found.

The specific imaging data points to be determined by a radiologist will be tumor and metastatic disease size, SUV uptake, specific anatomic structures involved with tumor, imaging irregularities and characteristics of those imaging irregularities of the involved structures locally and regionally (if present), imaging characteristics of the different phases of MRI (T1, T2, etc.), and any other notable imaging characteristic.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active head and neck cancer that require PET/CT regardless of the point of treatment
  • TNM staging I or II

Exclusion criteria

  • Patients whose primary treatment option is chemotherapy or radiation therapy (not surgical)
  • Implanted pacemakers
  • Intracranial aneurysm clips
  • Cochlear implants
  • Certain prosthetic devices
  • Implanted drug infusion pumps
  • Neurostimulators
  • Bone-growth stimulators
  • Certain intrauterine contraceptive devices; or
  • Any other type of iron-based metal implants.
  • MRI should not also be used on persons with the presence of internal metallic objects such as bullets or shrapnel, as well as surgical clips, pins, plates, screws, metal sutures, or wire mesh.
  • Subject with breast tissue expanders.

Treatment and study plan

Primary outcomes

  1. PET MRI as a Staging Tool for Head and Neck Cancer

    Time frame: 18 months

    Outcomes from this study will include a comparison of PET/MRI with PET/CT directly in a series of patients where surgical pathology specimens are available for correlation.

Sponsors and collaborators

Lead sponsor

Hoag Memorial Hospital Presbyterian

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 11, 2021
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.