NCT03429868

Brief Summary

Nasopharyngeal carcinoma (NPC) differs from other head and neck malignancies terms of its epidemiology, pathology, and treatment outcome. Integrated PET/MRI is a new imaging modality, which can simultaneously acquire PET and MRI images. Considering the lack of reports on the use of hybrid PET/MRI systems in prognosis prediction in NPC, the investigators conduct this prospective study to investigate the roles of integrated PET/MRI parameters for predicting treatment outcome and prognosis in patients with NPC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

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

August 1, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2020

Enrollment Period

5 years

First QC Date

February 6, 2018

Last Update Submit

May 9, 2023

Conditions

Keywords

Nasopharyngeal carcinomaNead neck cancerPrognosisPETMRI

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Being calculated from the date of diagnosis to the date of death or censor at the date of the last follow- up for surviving patients.

    3 years

Secondary Outcomes (1)

  • Recurrence-free survival

    3 years

Study Arms (1)

integrated PET/MRI

EXPERIMENTAL

The participants receive an integrated 18F-FDG PET/MRI during tumor staging.

Device: integrated PET/MRI

Interventions

The participants receive an integrated 18F-FDG PET/MRI scan in addition to the conventional 18F-FDG PET/CT on the same day during tumor staging. Whole body 18F-FDG PET/CT is performed one hour after injection of 10mCi of 18F-FDG. 18F-FDG PET/MRI is done after the PET/CT scan. And no additional 18F-FDG is given to the patients in the PET/MRI scan.

integrated PET/MRI

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven primary nasopharyngeal carcinoma
  • Age \> or = 20
  • Willing to receive therapy
  • The ability to provide written informed consent and receive the scheduled scans

You may not qualify if:

  • Woman with pregnancy or during lactation
  • A history of other malignancies or concomitant cancers in different anatomical locations
  • Not suitable to receive the PET scan such as serum glucose levels of \> 200 mg/dL or space phobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Related Publications (1)

  • Chan SC, Ng SH, Yeh CH, Lin YC, Lin CY, Wang JH, Cheng NM, Chen SH, Chang KP, Hsieh JC. Prognostic utility of 18F-FDG PET/MRI with intravoxel incoherent motion imaging in nasopharyngeal carcinoma. Eur J Nucl Med Mol Imaging. 2025 Dec;53(1):338-349. doi: 10.1007/s00259-025-07425-6. Epub 2025 Jul 2.

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Sheng-Chieh Chan

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 12, 2018

Study Start

August 1, 2015

Primary Completion

July 31, 2020

Study Completion

July 31, 2020

Last Updated

May 10, 2023

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations