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

NCT00245349 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2008-06-10

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

F-18 Fluorothymidine

Sponsors & Collaborators

  • University of Iowa

    lead OTHER

Principal Investigators

  • Yusuf Menda, MD · University of Iowa, Department of Radiology-Nuclear Medicine

  • Kenneth J Dornfeld, MD, PhD · University of Iowa

  • Timothy Tewson, PhD · University of Iowa, Department of Radiology-Nuclear Medicine

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Completion
2008-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00245349 on ClinicalTrials.gov