NCT04750434

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

4.5 years

First QC Date

February 8, 2021

Last Update Submit

October 9, 2024

Conditions

Head CancerNeck Cancer

Keywords

head cancerneck cancer

Outcome Measures

Primary Outcomes (1)

  • PET MRI as a Staging Tool for Head and Neck Cancer

    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.

    18 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who are referred to Hoag for imaging services related to Head and Neck cancer will be recruited.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 11, 2021

Study Start

March 3, 2020

Primary Completion

August 16, 2024

Study Completion

August 16, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations

US(1)