Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188253
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2005-09-09
Brief Title:
Positron Emission Tomography Scanning and Epstein-Barr Virus DNA Levels in the Staging and Follow-up of Nasopharyngeal Carcinoma
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Positron Emission Tomography Scanning and Epstein-Barr Virus DNA Levels in the Staging and Follow-up of Nasopharyngeal Carcinoma
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The standard treatment for nasopharyngeal cancer involves either radiation alone or radiation plus chemotherapy Before the start of treatmentpatients 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
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:
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 ie - 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
2 Nasopharyngeal carcinoma is associated with elevated titers of Epstein Barr virus EBV cell free plasma DNA Fluctuation ie - 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None