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Study to Calculate the Radiation Dosimetry in Subjects With Head and Neck Cancer

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clinicaltrials.gov/study/NCT00245349
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT002453490
Health Conditions in Trial
Head and neck cancer
Head and neck cancer
0
Trial Recruitment Size
90
Trial Sponsor
University of Iowa
University of Iowa
0
Clinical Trial Start Date
2005
0
Study Completion Date
2008
0
Clinical Trial Study Type
Observational0
Intervention Type
Procedure0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Participating Facility
‌
University of Iowa Hospitals and Clinics
0
Official Name
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) Study0
Last Updated
June 10, 2008
0

Other attributes

Intervention Treatment
F-18 Fluorothymidine0
Study 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 subject's response to therapy, or for clinical management of the subject.

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