Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245349
Status:
COMPLETED
Last Update Posted:
2008-06-10
First Post:
2005-10-25
Brief Title:
Study to Calculate the Radiation Dosimetry in Subjects With Head and Neck Cancer
Sponsor:
University of Iowa
Organization:
University of Iowa
Study Overview
Official Title:
Biodistribution and Radiation Dosimetry of F-18 Fluorothymidine FLT Imaged With Positron Emission Tomography PET in Patients With Head and Neck Cancer A Radioactive Drug Research Committee RDRC Study
Status:
COMPLETED
Status Verified Date:
2008-06
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:
Preliminary observations suggest positron emission tomography PET imaging with an F-18 labeled thymidine analog FLT can selectively identify proliferating and non-proliferating tissues including tumors FLT uptake in the tumor appears to reflect the level of cells undergoing DNA synthesis This is clinically important because cell proliferation markers have significant prognostic value both prior to initiating radiotherapy and as they change during the course of therapy In the proposed study the researchers assess the biodistribution and radiation dosimetry of FLT to obtain the necessary data to file an Investigational New Drug IND application with the Food and Drug Administration FDA The information collected under Radioactive Drug Research Committee RDRC approval will not be used for diagnostic purposes to assess the subjects response to therapy or for clinical management of the subject
Detailed Description:
There are approximately 40000 new cases of head and neck cancer each year in the United States Worldwide more than 500000 individuals will develop head and neck cancer each year ranking as the sixth most common cancer These cancers are predominately squamous cell cancers Approximately two thirds of subjects will present with locally advanced disease with either large disease at the primary site andor spread to regional lymph node levels
Despite aggressive treatment 5-year survival remains poor overall approximately 50 The major site of treatment failure is within the head and neck region with distant metastases occurring in approximately 25 of subjects and usually after local andor regional nodal failure
Current treatment options for locally advanced head and neck cancer include combinations of surgery radiation therapy and chemotherapy It is currently difficult to predict which combination will be best suited for any particular individual Rapid methods of assessing the response of subjects to chemo-radiotherapy would be a useful tool as it would permit the oncologist to change therapies either in type or degree in cases when the subject does not respond to the initial therapy regimen Current best methods of evaluating tumor response are either serial CT examinations so that changes in tumor size can be estimated or a fluorodeoxyglucose FDG positron emission tomography PET study in which changes in the metabolic status of the tumor are evaluated Unfortunately the anatomic information afforded by CT examinations often require months after treatment to allow the full effects of therapy to take place Even after this time the metabolic activity of any remaining tissue is nearly impossible to assess by CT scan making it difficult to distinguish between fibrosis and viable tissue Generally the FDG studies require 3-4 weeks after the end of the therapeutic regime before the relevant information is available with more reliable information obtained at 3-4 months after treatment
It is predictable that the most immediate signal of an anti-tumor therapeutic regime that has been successful is that the tumor cells will stop dividing proliferating after the therapy is initiated Therefore a tracer which is taken up into and retained in cells as a function of their proliferative activity should provide rapid information as to the effectiveness of the treatment It is the objective of this study to determine the biodistribution and radiation dosimetry of tracer F-18 3-deoxy-3-fluorothymidine This distribution data is essential before an Investigational New Drug IND application can be filed with the FDA that would allow the use of this tracer in clinical trials
Despite aggressive treatment 5-year survival remains poor overall approximately 50 The major site of treatment failure is within the head and neck region with distant metastases occurring in approximately 25 of subjects and usually after local andor regional nodal failure
Current treatment options for locally advanced head and neck cancer include combinations of surgery radiation therapy and chemotherapy It is currently difficult to predict which combination will be best suited for any particular individual Rapid methods of assessing the response of subjects to chemo-radiotherapy would be a useful tool as it would permit the oncologist to change therapies either in type or degree in cases when the subject does not respond to the initial therapy regimen Current best methods of evaluating tumor response are either serial CT examinations so that changes in tumor size can be estimated or a fluorodeoxyglucose FDG positron emission tomography PET study in which changes in the metabolic status of the tumor are evaluated Unfortunately the anatomic information afforded by CT examinations often require months after treatment to allow the full effects of therapy to take place Even after this time the metabolic activity of any remaining tissue is nearly impossible to assess by CT scan making it difficult to distinguish between fibrosis and viable tissue Generally the FDG studies require 3-4 weeks after the end of the therapeutic regime before the relevant information is available with more reliable information obtained at 3-4 months after treatment
It is predictable that the most immediate signal of an anti-tumor therapeutic regime that has been successful is that the tumor cells will stop dividing proliferating after the therapy is initiated Therefore a tracer which is taken up into and retained in cells as a function of their proliferative activity should provide rapid information as to the effectiveness of the treatment It is the objective of this study to determine the biodistribution and radiation dosimetry of tracer F-18 3-deoxy-3-fluorothymidine This distribution data is essential before an Investigational New Drug IND application can be filed with the FDA that would allow the use of this tracer in clinical trials
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