NCT04417985

Brief Summary

Nasopharyngeal carcinoma (NPC) differs from other head and neck malignancies terms of its epidemiology, pathology, and treatment outcome. Although NPC is a radiosensitive tumor, distant recurrence remains a clinical challenge. Therefore, the investigators conducted this study to prospectively investigate the role of imaging and blood biomarkers in predicting the prognosis of NPC patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

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, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2014

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
Last Updated

August 21, 2024

Status Verified

May 1, 2020

Enrollment Period

3 years

First QC Date

May 28, 2020

Last Update Submit

August 19, 2024

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free survival

    The time between the end of chemoradiotherapy and the date of recurrence or censored at the date of the last follow-up

    5 years

Study Arms (1)

18F-FDG PET/CT with MRI and blood sampling

EXPERIMENTAL

The enrolled subjects received 18F-FDG PET/CT and MRI before, during, and after the primary definitive treatment. The blood sample was collected on the same day of PET/CT scan.

Device: 18F-FDG PET/CT, MRI

Interventions

18F-FDG PET/CT, MRIDEVICE
18F-FDG PET/CT with MRI and blood sampling

Eligibility Criteria

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

You may qualify if:

  • Biopsy proved primary M0 nasopharyngeal carcinoma

You may not qualify if:

  • Woman with pregnancy or during lactation
  • A history of other malignancies or presence of recurrent tumors
  • A serum glucose level \> 200mg/dL before PET scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

May 28, 2020

First Posted

June 5, 2020

Study Start

August 1, 2011

Primary Completion

July 31, 2014

Study Completion

July 31, 2014

Last Updated

August 21, 2024

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share