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Hypoxia Imaging With 18F FAZA. Prognostic Impact in Cervical Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by Medical University of Vienna.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00388687
First Posted: October 17, 2006
Last Update Posted: October 17, 2006
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:
Medical University of Vienna
  Purpose
The aim of this study is to visualize the tumor hypoxic tissue, the potential quantitative changes and the biological behavior of cervical carcinoma (primary and / or lymph nodes) before, during and after radiochemotherapy with the novel hypoxia PET tracer 18FAZA.

Condition Intervention Phase
Uterine Cervical Neoplasms Drug: 18F Fluoroazomycin Arabinoside (FAZA) Phase 2

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Hypoxia Imaging With the Novel Radiopharmaceutical 18F Fluoroazomycin Arabinoside (FAZA)- Prognostic Impact in Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Estimated Enrollment: 25
Study Start Date: July 2006
Estimated Study Completion Date: July 2007
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First diagnosis of histologically proven cervical cancer FIGO stage IB2 to IVA.
  • Treatment intention for the purpose of achieving cure
  • Age < 80 years
  • No previous standard or radical hysterectomy

Exclusion Criteria:

  • Pregnancy, breast-feeding women, patients that are not able to lie motionless for one hour.Palliative treatment, recurrent disease, neoadjuvant chemotherapy, other pre-existing malignancies, age > 80 years,
  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): NCT00388687


Contacts
Contact: Matthias Schuetz, M.D. 00431404005550 matthias.schuetz@meduniwien.ac.at
Contact: Barbara Bachtiary, Prof. M.D 00431404007676 barbara.bachtiary@meduniwien.ac.at

Locations
Austria
Medical Universitiy of Vienna Recruiting
Vienna, Austria, 1090
Contact: Barbara Bachtiary, Prof. M.D.    00431404007676    barbara.bachtiary@meduniwien.ac.at   
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Barbara Bachtiary, Prof. M.D.    00431404007676    barbara.bachtiary@meduniwien.ac.at   
Principal Investigator: Georgios Karanikas, Prof. M.D.         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Study Director: Georgios Karanikas, Prof. M.D. Medical Universitiy of Vienna
  More Information

ClinicalTrials.gov Identifier: NCT00388687     History of Changes
Other Study ID Numbers: EK Nr: 241/2006
First Submitted: October 16, 2006
First Posted: October 17, 2006
Last Update Posted: October 17, 2006
Last Verified: October 2006

Keywords provided by Medical University of Vienna:
Hypoxia
FAZA
PET
Radiochemotherapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Anoxia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Signs and Symptoms, Respiratory
Signs and Symptoms