Nasopharyngeal CarcinomaNCT00188253
Positron Emission Tomography Scanning and Epstein-Barr Virus DNA Levels in the Staging and Follow-up of Nasopharyngeal Carcinoma.
An observational study of Nasopharyngeal Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nasopharyngeal Carcinoma
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2005to Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Princess Margaret Hospital, University Health Network
Toronto, Ontario, M5G 2M9
About this study
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.
Read the detailed description
- 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.
- 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.
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal carcinoma, PET scan, MRI, EBV virus
- Medical subject headings
- Nasopharyngeal Carcinoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eugene Yu, MD, Principal investigator, University Health Network, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188253
- Sponsor's protocol ID
- 04-0264-C
- Status last verified
- Oct 2022
- First submitted
- 9 Sep 2005
- Last updated
- 18 Oct 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography Scanning and Epstein-Barr Virus DNA Levels in the Staging and Follow-up of Nasopharyngeal Carcinoma.
- ClinicalTrials.gov ID
- NCT00188253
- Acronym / sponsor ID
- 04-0264-C
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- Nasopharyngeal carcinoma, PET scan, MRI, EBV virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Yu, MD principal investigator
University Health Network, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.