Positron Emission Tomography Scanning and Epstein-Barr Virus DNA Levels in the Staging and Follow-up of Nasopharyngeal Carcinoma.

October 17, 2022 updated by: University Health Network, Toronto

The standard treatment for nasopharyngeal cancer involves either radiation alone or radiation plus chemotherapy. Before the start of treatment,patients require an imaging scan to assess the extent of disease. The most commonly used test is a magnetic resonance imaging (MRI) scan.

The goal of the study is to examine the value of a new imaging technology that has recently become available at the University Health Network Hospitals called Positron Emission Tomography scanning (PET). PET scanning involves the injecting a small amount of a drug through a vein in the arm called 18-fluorodeoxyglucose (18FDG). This drug is special in that it is radioactive and will be detected by the PET machine. Cancer cells are believed to be more active than normal cells and have a high rate of metabolism. Therefore, cancer cells are thought to take up glucose (a kind of sugar) faster than normal cells in the body. Because 18FDG is a modified type of glucose, it is also taken up by cancer cells. Special imaging cameras will be able to visualize the areas of uptake and reveal sites of cancer involvement. The main goal of this study is to evaluate whteher the scan is able to detect the presence of nasopharyngeal carcinoma (NPC) both before and after treatment and to specifically compare it to findings on magnetic resonance imaging scans (MRI).

In addition to doing the PET scans, we are asking patients to have blood samples drawn throughout their treatment and follow-up, for a research test called Epstein Barr virus (EBV) DNA levels. The Epstein Barr virus is thought to have a role in the development of nasopharyngeal cancer, and many patients with nasopharyngeal carcinoma are found to have high levels of EBV DNA levels in their blood. The second goal of this study is to evaluate whether changes in EBV DNA levels are associated with the treatment and the disease course in nasopharyngeal cancer, and whether they help to predict any changes in the cancer. This part of the study involves the sampling of a small amount of venous blood at a time prior to the beginning of therapy and at regular intervals following treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

  1. Patients with nasopharyngeal carcinoma are staged according to the 2002 American Joint Committee on Cancer (AJCC) criteria. MRI is the imaging modality of choice for staging and follow-up of nasopharyngeal carcinoma. The goal is to conduct a pilot study to compare the staging findings on MRI with those on PET scanning in both pre- and post-therapy patients. The end point is to document the degree of concordance between the two modalities with respect to the anatomic location and volume of disease at the time of initial staging and on follow up and to determine how any differences observed may alter staging and management including radiation planning. We hypothesize that PET scanning will be able to detect recurrence and residual disease within the radiated tissue earlier than MRI.
  2. Nasopharyngeal carcinoma is associated with elevated titers of Epstein Barr virus (EBV) cell free, plasma DNA. Fluctuation i.e. - elevation in EBV DNA levels following therapy may serve as a potential marker for recurrent or residual disease. We believe that a change in EBV DNA titer precedes changes on conventional MRI and possibly PET scans in patients with recurrent disease. We also predict, that due to its sensitivity, that EBV titer levels will be more sensitive in the evaluation of tumor response to therapy, as well predicting tumor recurrence. The second goal is to conduct a trial to compare the sensitivity of MRI, PET and EBV titers in the assessment of recurrent disease.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital, University Health Network

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically diagnosed nasopharyngeal carcinoma presenting to the University Health Network for which a course of curative radiation therapy +/- chemotherapy is planned.

Description

Inclusion Criteria:

- 1. Patients with histologically diagnosed nasopharyngeal carcinoma presenting to the University Health Network for which a course of curative radiation therapy +/- chemotherapy is planned.

2. Patient is able to provide informed consent and is willing to adhere to the study protocol.

Exclusion Criteria:

- 1. Patients with metastatic disease. 2. Lactating or pregnant females. 3. Medical or psychological conditions such as claustrophobia, etc., that in the opinion of the referring MD or study investigator, would make the patient unable to tolerate the study procedures.

4. Presence of a second malignancy or a history of another malignancy active within the last 5 years, with the exception of non-head and neck, non-melanomatous cutaneous malignancy.

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

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Eugene Yu, MD, University Health Network, University of Toronto

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

March 1, 2005

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-0264-C

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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