Prognostic Utility of the Imaging and Biological Signatures in Nasopharyngeal Carcinoma

August 19, 2024 updated by: Chang Gung Memorial Hospital

Integrating Biomarkers From Serum/Plasma and Molecular Images to Predict Occult Distant Metastases in Nasopharyngeal Carcinoma Patients With M0 Disease

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. Background:

    Nasopharyngeal carcinoma (NPC) differs from other head and neck malignancies terms of its epidemiology, pathology, and treatment outcome. NPC has a good 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 good prognostic model for the development of distant failure for NPC patients is still lacking. It is well known that Epstein-Barr virus (EBV) genomes are present in almost every NPC tumor cell, irrespective of histologic differentiation and geographic distribution. Various EBV-derived/related factors, therefore, have been used as NPC tumor markers, including EBV-specific viral capsid antigen (VCA) IgA and cell-free EBV DNA. The measurement of cell-free EBV DNA load has already been shown to be a good pretreatment prognostic indicator. Another important feature of NPC is that the tumors are characterized by heavy infiltration of nonmalignant lymphocytes and might play an important role in tumorigenesis; and cytokines and chemokines may represent the key mediators of this interaction. Compelling evidence has also emerged in recent years suggesting that cytokines and chemokines play important roles in regulating processes critical to tumor progression, such as proliferation and metastasis.

    Beyond blood biomarkers, standard uptake value (SUV) from FDG PET could predict treatment failure in NPC patients. On the other hand, apparent diffusion coefficient (ADC) from diffusion-weighted MRI (DWI) has been shown to be an important prognostic marker in cancer patients, including head and neck cancer.

  2. Aim:

    To investigate the roles of imaging and blood biomarkers in predicting distant failures, recurrences, and survival in NPC patients.

  3. Study design:

Study participants:

Patients with a histological diagnosis of primary M0 NPC were deemed eligible. All study participants received both 18F-FDG PET/CT and head-neck MRI imaging before treatment, during radiotherapy, and 3 months after the definitive treatment. The blood sample was collected on the same day of the PET/CT scan.

18F-FDG PET/CT: Study participants were instructed to fast for six hours before the PET study. FDG (370-444 MBq) was administered intravenously. No intravenous contrast material was administered for CT scans. The participants underwent head to mid-thigh scans. PET and CT images were acquired consecutively 50 to 70 minutes after the injection of 18F-FDG. Before PET acquisition, a standard helical CT scan was acquired from the head to the proximal thighs using the manufacturer's dose reduction software. The PET images were reconstructed using the CT data for attenuation correction and an ordered subsets expectation maximization iterative reconstruction algorithm.

MRI :

MRI was performed at 3 Tesla (MAGNETOM® Trio with Tim; Siemens Medical Solutions, Bonn, Germany). Dedicated MRI of the head and neck region was obtained in the axial projection with T1-weighted turbo spin echo (TSE) sequence and subsequently with T2-weighted TSE sequences with fat saturation. After intravenous administration of gadopentetate dimeglumine (Magnevist; Schering, Berlin, Germany) at 3 mL/sec with a dose of 0.1 mmol/kg, MRI of the head and neck region was performed using a fat-saturated T1-weighted TSE sequence in the axial and coronal planes. DWI was acquired using single shot spin-echo echo-planar imaging with a modified Stejskal-Tanner diffusion gradient pulsing scheme.

Collection and storage of blood plasma:

Ten-milliliter samples of peripheral blood were drawn from subjects using standardized phlebotomy procedures and collected into an EDTA tube for isolation of plasma. Blood samples were centrifuged at 2000×g. Plasma was immediately aliquoted, transferred into plain polypropylene tubes, and was stored in a dedicated freezer at -80°C. No more than one freeze-thaw cycle was allowed for each plasma sample.

Statistical analysis:

Recurrence-free survival (RFS) and overall survival (OS) served as main outcome measures. RFS was 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. Distant failure-free survival was also calculated from the date of diagnosis to the date of documented distant recurrences, or censored at the last follow-up date. OS was calculated from the date of diagnosis to the date of death or censor at the date of the last follow-up for surviving study participants. The cutoff values for the clinical variables, blood biomarkers, and imaging parameters in survival analysis were determined using the log-rank test based on the RFS and OS rates observed in the entire study cohort. Survival curves were plotted using the Kaplan-Meier method. The effect of each individual variable was initially evaluated using univariate analysis. Cox regression models were used to identify the predictors of survival. Two-tailed P values < 0.05 were considered statistically significant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Biopsy proved primary M0 nasopharyngeal carcinoma

Exclusion Criteria:

  • 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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 18F-FDG PET/CT with MRI and blood sampling

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: 5 years
The time between the end of chemoradiotherapy and the date of recurrence or censored at the date of the last follow-up
5 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSC 100-2314-B-182A-053

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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