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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jörg Kotzerke, Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00180180
First received: September 13, 2005
Last updated: March 15, 2016
Last verified: March 2016
  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 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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: September 13, 2005
Last Updated: March 15, 2016
Health Authority: Germany: Fedaral Office for Radiation Protection

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

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

ClinicalTrials.gov processed this record on August 25, 2016