PET and MRI in Prognosis Prediction of NPC

May 9, 2023 updated by: Chang Gung Memorial Hospital

Prognostic Value of the Integrated PET/MRI in Patients With Nasopharyngeal Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Background:

    Nasopharyngeal carcinoma (NPC) has a higher local tumor control rate but a higher incidence of distant metastasis compared with squamous cell carcinomas of other regions of the head and neck. Thus, it's usually considered a distinct study group. A reliable clinical prognostic factor for NPC patients is still lacking. Positron emission tomography (PET) with 2- [fluorine- 18]fluoro-2-deoxy-D-glucose (18F-FDG)/computed tomography (CT) has been used extensively for diagnosis and assessment of prognosis in NPC in recent years. Several PET-derived imaging parameters such as standardized uptake value (SUV), metabolic tumor volume (MTV), or total lesion glycolysis (TLG) have been proposed as potential prognosticators in NPC. MRI functional parameters also play a role to assess the cellular or molecular change of head and neck cancer. Diffusion-weighted MR imaging (DWI) is a technique, which can quantify the diffusion of water molecules in tissues using apparent diffusion coefficient (ADC). ADC is inversely correlated with cellular density. Dynamic contrast-enhanced perfusion MR imaging (DCE-MRI) is another MRI technique based on sequential imaging obtained during the passage of a contrast of agent through the tissue. It enables probing the microvascular environment in the tumor tissue.

    Integrated PET/MRI is a new imaging modality, which can simultaneously acquire PET and MRI images. Traditionally, PET and MRI images were acquired on different dates and were fused by commercial software. Problems caused by a separate system include SUV or MRI parameters were reported to be different if the scans were acquired on different days. Simultaneous acquisition of PET and MRI images would solve these problems.

  2. Aim: The investigators conduct this prospective study to investigate the roles of integrated PET/MRI imaging parameters for predicting treatment outcomes and prognosis in patients with NPC.
  3. Study design:

Patients: All patients receive whole-body 18F-FDG PET/MRI following 18F-FDG-PET/CT on the same day. For tumor staging, the 7th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) cancer staging system is used. The patients with stage I disease are treated with definitive radiation therapy alone, while patients with stage II-IVB are treated with concurrent chemoradiotherapy. Patients with metastatic disease (stage IVC) are treated with standard platinum-based chemotherapy.

18F-FDG PET/CT: All study patients fast for at least 6 h before 18F-FDG PET/CT imaging. Scans are performed using a Biograph mCT scanner (Siemens Medical Solutions, Malvern, PA, USA) consisting of a four-ring PET scanner (axial field-of-view [FOV] = 22.1 cm, transaxial FOV = 70 cm) and a 40-section CT scanner.

Whole-body 18F-FDG PET/MRI: PET/MRI is performed on a Biograph mMR (Siemens Healthcare, Erlangen, Germany) following the PET/CT scan on the same day. The PET/MRI system is equipped with 3-T magnetic field strength, total imaging matrix coil technology covering the entire body with multiple integrated radiofrequency surface coils, and a fully functional PET system with avalanche photodiode technology embedded in the magnetic resonance gantry.

Image interpretation: The PET/CT and PET/MRI data sets are evaluated on dedicated workstations (Syngo.via, Siemens Healthcare, Erlangen, Germany). The readers interpret the (1) MR images from PET/MRI, (2) 18F-FDG PET/MRI images, and (3) 18F-FDG PET/CT images independently. They are aware of the study protocol but are blinded to the results from the other imaging modalities. Imaging parameters including SUV, MTV, TLG, ADC, Ktrans, Ve, and Vp are calculated.

Statistical analysis: Overall survival (OS) and recurrence-free survival (RFS) serves as the main outcome measures. OS is calculated from the date of diagnosis to the date of death or censored at the date of the last follow-up for surviving patients. RFS is defined as the time between the end of treatment and the date of recurrence (tumor relapse or death) or censored at the date of the last follow-up. The cutoff values for the clinical variables and imaging parameters in survival analysis are determined using the log-rank test based on the RFS and OS rates observed in the entire study cohort. Survival curves are plotted using the Kaplan-Meier method. The effect of each individual variable is initially evaluated using univariate analysis. Cox regression models are used to identify the predictors of survival. Two-tailed P values < 0.05 are considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan, Taiwan
        • Linkou Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Biopsy proven primary nasopharyngeal carcinoma
  2. Age > or = 20
  3. Willing to receive therapy
  4. The ability to provide written informed consent and receive the scheduled scans

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: integrated PET/MRI
The participants receive an integrated 18F-FDG PET/MRI during tumor staging.
Device: integrated PET/MRI

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: 3 years
The time between the end of treatment and the date of recurrence (tumor relapse or death) or censor at the date of the last follow-up.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Sheng-Chieh Chan, Chang Gung memorial hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

February 6, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSC 104-2314-B-182A-084-MY3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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