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Tumor Hypoxia of Head-and-neck Cancer Underwent Radiation Therapy Measured With F-18-FMISO

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180180
First Posted: September 16, 2005
Last Update Posted: March 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jörg Kotzerke, Technische Universität Dresden
  Purpose
The purpose of this study is to describe the regional and global tumor hypoxia in head-and-neck cancer during percutaneous radiation therapy

Condition Phase
Head and Neck Neoplasms Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tumor Hypoxia of Head-and-neck Cancer Underwent Radiation Therapy Measured With F-18-FMISO

Resource links provided by NLM:


Further study details as provided by Jörg Kotzerke, Technische Universität Dresden:

Enrollment: 60
Study Start Date: July 2006
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study includes consecutive patients from the Department of Radiooncology with head and neck cancer (HNC) intended for a curative chemoradiotherapy.
Criteria

Inclusion Criteria:

  • histologically confirmed head-and-neck cancer not curable by surgery
  • Karnofsky > 70%
  • tumor volume and localisation allow curative radiotherapy
  • written consent

Exclusion Criteria:

  • metastases
  • earlier radiation therapy of head and neck
  • pregnancy
  • secondary malignancy excluding dermal carcinoma and Tis-carcinoma of cervix uteri
  • psychiatric impairment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180180


Locations
Germany
Department of Nuclear Medicine
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Joerg Kotzerke, MD Department of Nuclear Medicine
  More Information

Responsible Party: Jörg Kotzerke, Prof. Dr., Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT00180180     History of Changes
Other Study ID Numbers: HNO-FMISO-FU
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Jörg Kotzerke, Technische Universität Dresden:
head-and-neck cancer
radiation therapy
F-18-FMISO

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms